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

Catalog Number	364951
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/08/2020
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 #: unknown, medical device expiration date: unknown, device manufacture date: unknown, medical device lot #: 9315367, medical device expiration date: 2021-05-31, device manufacture date: 2019-11-11.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported during use the bd vacutainer® c&s preservative urine tube experienced erroneous results.The following information was provided by the initial reporter was translated from (b)(6) to english: the customer stated ¿(b)(6) year old female patient, goes to the laboratory.Sample is received verifying compliance with collection requirements (pre-cleaning, medium stream urine, sample reception time less than 2 hours from collection, without consumption or application of antibiotics or antiseptics).The sample is processed and it proceeds to sow in enrichment, selective and differential media.The following urinary sediment is observed: epithelial cells: 48 cél / ul leukocytes: greater than 500 cél / ul erythrocytes: 82 cél / ul bacteria: rare urinary sediment is confirmed by means of flow cytometry, checking for the presence of bacteria and with a preliminary result of pure population of gram negative on histograms.Gram staining is performed by checking the reported population by cytometry.After the 24 hour incubation period ended, no development of bacterial colonies was observed; the modified enrichment technique for biofilm-forming bacteria is carried out and it is left in incubation for 24 hours.After the incubation time, no growth was observed.It is worth mentioning that it is not the first time that we have such a case.¿.
Additional Manufacturer Narrative
H.6.Investigation: bd had not received samples or photos for the investigation.Due to no samples and/ or photos being received, the manufacturing investigation was limited.The device history records were reviewed with no issues being identified.There were no related quality notifications.All process and final inspections comply with specification requirements.
Event or Problem Description
It was reported during use the bd vacutainer® c&s preservative urine tube experienced erroneous results.The following information was provided by the initial reporter was translated from spanish to english: the customer stated ¿34-year-old female patient, goes to the laboratory.Sample is received verifying compliance with collection requirements (pre-cleaning, medium stream urine, sample reception time less than 2 hours from collection, without consumption or application of antibiotics or antiseptics).The sample is processed and it proceeds to sow in enrichment, selective and differential media.The following urinary sediment is observed: epithelial cells: 48 cél / ul leukocytes: greater than 500 cél / ul erythrocytes: 82 cél / ul bacteria: rare urinary sediment is confirmed by means of flow cytometry, checking for the presence of bacteria and with a preliminary result of pure population of gram negative on histograms.Gram staining is performed by checking the reported population by cytometry.After the 24 hour incubation period ended, no development of bacterial colonies was observed; the modified enrichment technique for biofilm-forming bacteria is carried out and it is left in incubation for 24 hours.After the incubation time, no growth was observed.It is worth mentioning that it is not the first time that we have such a case.¿.

• 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
• MDR Report Key: 10356655
• Report Number: 1917413-2020-00644
• Device Sequence Number: 3551764
• Product Code: JSM
• UDI-Device Identifier: 50382903649513
• UDI-Public: 50382903649513
• Combination Product (Y/N): N
• Initial Reporter Country: MX
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/29/2020

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 Catalogue Number: 364951
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 07/13/2020
• Initial Report FDA Received Date: 08/03/2020
• Supplement Report FDA Received Date: 09/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 34 YR