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	Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the bd vacutainer® c&s preservative urine tube experienced tube use after expiration date which was noted during use.The following information was provided by the initial reporter: material no: 364951, batch no: unknown.It was reported the tubes were post expiration.The customer is inquiring on if this will affect the growth or over growth.Customer did not want to make this a complaint, customer just wanted information on the results.No further information will be provided.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.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.H3 other text : see section h.10.
Event or Problem Description
It was reported that the bd vacutainer® c&s preservative urine tube experienced tube use after expiration date which was noted during use.The following information was provided by the initial reporter: material no: 364951; batch no: unknown.It was reported the tubes were post expiration.The customer is inquiring on if this will affect the growth or over growth.Customer did not want to make this a complaint, customer just wanted information on the results.No further information will be provided.

• 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: 9309564
• Report Number: 1917413-2019-02338
• Device Sequence Number: 13958041
• Product Code: JSM
• UDI-Device Identifier: 50382903649513
• UDI-Public: 50382903649513
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 11/12/2019

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: 07/11/2019
• Supplement Date Received by Manufacturer: 07/11/2019
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 11/12/2019
• 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