MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® C&S PRESERVATIVE URINE TUBE; TRANSPORT CULTURE MEDIUM

Model Number	364951
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/03/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 1005200.Medical device expiration date: 2022-07-31.Device manufacture date: 2021-01-05.Medical device lot #: 1005212.Medical device expiration date: 2022-07-31.Device manufacture date: 2021-01-05.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd vacutainer® c&s preservative urine tube, the device experienced erroneous results.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: dr.Reported that during the validation of the c&s tube (urine - gray cap) they were recovering few microorganisms in the culture medium.The validation is being carried out as following: selection of urine samples without microorganisms.Realization of bacterial suspension (e.Coli atcc 25922) in 0.5mf scale and serial dilutions until obtaining 50 cfu on the plate.Inoculation of the bacterial suspension in the c&s tube containing the negative urine.Incubation of the c&s tube and inoculation in agar at times zero, 6h, 12h and 24h.A sample inoculation from the blue cap primary tube is also performed.Reading of agar plates.It was reported that when reading the agar plates, the quantification of cfu was much lower after 12 hours of incubation in the c&s tube, causing little recovery of microorganisms.Dilutions must be performed on urine samples; microorganism tested: e.Coli from recent growth in cps, prepare suspensions with turbidity equivalent to the 0.5 standard on the mcfarland scale; identify tubes 10e7 to 10e5; put 30 ml of urine in the blue bottle and then withdraw 0.3 ml and discard; add 0.3 ml of bacterial or yeast suspension; homogenize and transfer to the tube containing boric acid; homogenize and seed 50 microliters in 1 as plate and 1 cps plate (time zero); incubate, count the number of colonies on each plate and average.Expected is 75 ufc per card; leave the tube with urine containing ac.Boric at room temperature; identify the colonies in maldi; tabulate the number of colonies obtained at different times for each species.
Event or Problem Description
It was reported when using the bd vacutainer® c&s preservative urine tube, the device experienced erroneous results.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: dr.Reported that during the validation of the c&s tube (urine - gray cap) they were recovering few microorganisms in the culture medium.The validation is being carried out as following: 1) selection of urine samples without microorganisms.2) realization of bacterial suspension (e.Coli atcc 25922) in 0.5mf scale and serial dilutions until obtaining 50 cfu on the plate.3) inoculation of the bacterial suspension in the c&s tube containing the negative urine.4) incubation of the c&s tube and inoculation in agar at times zero, 6h, 12h and 24h.A sample inoculation from the blue cap primary tube is also performed.5) reading of agar plates.It was reported that when reading the agar plates, the quantification of cfu was much lower after 12 hours of incubation in the c&s tube, causing little recovery of microorganisms.- dilutions must be performed on urine samples; - microorganism tested: e.Coli - from recent growth in cps, prepare suspensions with turbidity equivalent to the 0.5 standard on the mcfarland scale; - identify tubes 10e7 to 10e5; - put 30 ml of urine in the blue bottle and then withdraw 0.3 ml and discard; - add 0.3 ml of bacterial or yeast suspension; - homogenize and transfer to the tube containing boric acid; - homogenize and seed 50 microliters in 1 as plate and 1 cps plate (time zero); - incubate, count the number of colonies on each plate and average.Expected is 75 ufc per card; - leave the tube with urine containing ac.Boric at room temperature; - identify the colonies in maldi; - tabulate the number of colonies obtained at different times for each species info added on 30.Aug.2021: this is for both pr 3345425 and 3079216 (same customer) - is this all taking place for validation of the urine tube 364951? r: yes; - has this worked before with other lot #'s? r: no; - how old are the strains that are being used? how many passes have occured? r: customer uses recent raise strains, with growth from 18h to 24h; - have they tried a new (fresh ) atcc organism? r: yes; - was there any change with the proposed revised protocol (we proposed a second step to the customer and asked to send 2 new batches to carry out the same validation.Below is the protocol used:) ** did they get they expected growth? r: customer tried, but the results obtained were similar from previous.
Additional Manufacturer Narrative
Additional information was received that changed the reportability of this complaint.Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 1005200 d.4.Medical device expiration date: 2022-07-31 h.4.Device manufacture date: 2021-01-05 d.4.Medical device lot #:1005212 d.4.Medical device expiration date: 2022-07-31 h.4.Device manufacture date: 2021-01-05 d.4.Medical device lot #: 0289323 d.4.Medical device expiration date: 2022-04-30 h.4.Device manufacture date: 2020-10-15 d.4.Medical device lot #: 0343501 d.4.Medical device expiration date: 2022-06-30 h.4.Device manufacture date: 2020-12-08.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-12-15.H6: investigation summary it was reported that during a validation test, customers experienced poor recovery of microorganisms from the c&s tube.Bd received 99 samples from lot 1005200, 100 samples from lot 1005212, 199 samples from lot 0343501, and 81 samples from lot 0289323 and 5 photos were received for catalog 364951.The customer samples were evaluated along with retention samples of the incident lot selected from bd inventory.The samples were tested and no issues relating to erroneous results/low recovery were observed.According to this testing, the data demonstrated that the average colony counts of the 3 control lots (1005214, 0289321, and 1005212) and the 3 test lots (0343501, 1005200, and 0289323) of the urine c&s tubes did decrease over time.From the initial timepoint (0 h) average colony count was between 60-80 cfu and then 24 hours later average colony count was between 13-40 cfu.For organism recovery in a urine transport device ¿to be considered acceptable, plate counts shall remain within 1 log10 of the initial microorganism concentration for each microorganism tested.The results of this study, although decreasing over time and only an average of 2 replicates, are still within 1 log10 and would be considered acceptable performance per clsi guidelines and bd claims.Additionally, 20 customer samples from each lot affected were tested for solubility by filling with water until vacuum was exhausted and then shaking tube for 20 seconds.The additive dissolved in all tubes tested within the 20 seconds.100 retention samples were inspected with no issues identified.The photos show petri dishes with organisms growing on the media.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint is unable to be confirmed for the indicated failure mode, as all retain and customer samples performed as expected.H3 other text : see h10.
Event or Problem Description
It was reported when using the bd vacutainer® c&s preservative urine tube, the device experienced erroneous results.This event occurred ten times.The following information was provided by the initial reporter.The customer stated: dr.Reported that during the validation of the c&s tube (urine - gray cap) they were recovering few microorganisms in the culture medium.The validation is being carried out as following: 1) selection of urine samples without microorganisms.2) realization of bacterial suspension (e.Coli atcc 25922) in 0.5mf scale and serial dilutions until obtaining 50 cfu on the plate.3) inoculation of the bacterial suspension in the c&s tube containing the negative urine.4) incubation of the c&s tube and inoculation in agar at times zero, 6h, 12h and 24h.A sample inoculation from the blue cap primary tube is also performed.5) reading of agar plates.It was reported that when reading the agar plates, the quantification of cfu was much lower after 12 hours of incubation in the c&s tube, causing little recovery of microorganisms.Dilutions must be performed on urine samples; microorganism tested: e.Coli from recent growth in cps, prepare suspensions with turbidity equivalent to the 0.5 standard on the mcfarland scale; identify tubes 10e7 to 10e5; put 30 ml of urine in the blue bottle and then withdraw 0.3 ml and discard; add 0.3 ml of bacterial or yeast suspension; homogenize and transfer to the tube containing boric acid; homogenize and seed 50 microliters in 1 as plate and 1 cps plate (time zero); incubate, count the number of colonies on each plate and average.Expected is 75 ufc per card; leave the tube with urine containing ac.Boric at room temperature; identify the colonies in maldi; tabulate the number of colonies obtained at different times for each species.

• Brand Name: BD VACUTAINER® C&S PRESERVATIVE URINE TUBE
• Common Device Name: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer (Section G): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12358306
• Report Number: 1917413-2021-00778
• Device Sequence Number: 14539400
• Product Code: JSM
• UDI-Device Identifier: 50382903649513
• UDI-Public: 50382903649513
• Combination Product (Y/N): N
• Initial Reporter Country: BR
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 364951
• Device Catalogue Number: 364951
• Device Lot Number: SEE H.10.
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/15/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/03/2021
• Supplement Date Received by Manufacturer: 08/24/2021; 02/17/2022
• Initial Report FDA Received Date: 08/24/2021
• Supplement Report FDA Received Date: 09/01/2021; 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown