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 Known Impact Or Consequence To Patient (2692)
Date of Event	05/13/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr: 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 that erroneous results occurred with a bd vacutainer® c&s preservative urine tube.The following information was provided by the initial reporter, "we are simply trying to rule out contamination issues by eliminating the tubes.There is no foundation for the inquiry¿ just simply asking if anything has been identified or reported to bd, to simply rule the tubes out as the reason for high contamination rates.We were a part of a study in the past where we identified something with the plates we were using, because of the results we were seeing, so we notified the vendors and then found out there was an issue with the plates that we weren¿t made aware of.So let¿s see what bd reports¿ maybe it will be nothing.But that will help us rule the tubes out.And that¿s really all we¿re trying to do here.".
Event or Problem Description
It was reported that erroneous results occurred with a bd vacutainer® c&s preservative urine tube.The following information was provided by the initial reporter, "we are simply trying to rule out contamination issues by eliminating the tubes.There is no foundation for the inquiry just simply asking if anything has been identified or reported to bd, to simply rule the tubes out as the reason for high contamination rates.We were a part of a study in the past where we identified something with the plates we were using, because of the results we were seeing, so we notified the vendors and then found out there was an issue with the plates that we weren¿t made aware of.So let¿s see what bd reports maybe it will be nothing.But that will help us rule the tubes out.And that¿s really all we¿re trying to do here.".
Additional Manufacturer Narrative
Investigation: investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Additionally, bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Bd technical services conducted troubleshooting with the customer, and communicated that there are no known issues with this specific catalog number.The customer has indicated that they consider this matter to the resolved.Investigation conclusion: as no samples or photos were received for evaluation, the customer's indicated failure mode was not observed by bd.Root cause description: as there was no sample or photo available for evaluation, a root cause could not be determined.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.

• 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: 8654971
• Report Number: 1917413-2019-01543
• Device Sequence Number: 16706121
• Product Code: JSM
• UDI-Device Identifier: 50382903649513
• UDI-Public: 50382903649513
• Combination Product (Y/N): N
• Initial Reporter State: IN
• Initial Reporter Country: US
• PMA/510(K) Number: K024240
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 364951
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/13/2019
• Supplement Date Received by Manufacturer: 05/13/2019
• Initial Report FDA Received Date: 05/30/2019
• Supplement Report FDA Received Date: 06/13/2019
• 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