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	06/14/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The following information was provided by the initial reporter.The customer stated: low recovery of microorganisms after incubation of the c&s tube for 12 hours.Physician reported that during the validation of the c&s tube (urine - gray cap) they were managing to recover few microorganisms in the culture medium.There was no patient impact.
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 81 samples for investigation.5 photos were provided.The photos show petri dishes with the appearance of organism growth.No photos of the actual vacutainer tube was seen.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 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.Retention samples were also inspected with no issues identified.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.
Event or Problem Description
It was reported when using the bd vacutainer® c&s preservative urine tube, the device experienced erroneous results.The following information was provided by the initial reporter.The customer stated: low recovery of microorganisms after incubation of the c&s tube for 12 hours.Physician reported that during the validation of the c&s tube (urine - gray cap) they were managing to recover few microorganisms in the culture medium.There was no patient impact.

• 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: 12123300
• Report Number: 1917413-2021-00577
• Device Sequence Number: 14325248
• 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
• 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 Expiration Date: 04/30/2022
• Device Model Number: 364951
• Device Catalogue Number: 364951
• Device Lot Number: 0289323
• 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: 06/14/2021
• Supplement Date Received by Manufacturer: 02/17/2022
• Initial Report FDA Received Date: 07/06/2021
• Supplement Report FDA Received Date: 02/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/15/2020
• 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