MAUDE Adverse Event Report: BECTON, DICKINSON & CO. (BROKEN BOW) BD VACUTAINER® URINE ANALYSIS PRESERVATIVE TUBE; SPECIMEN TRANSPORT AND STORAGE CONTAINER

Catalog Number 364992

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 04/03/2019

Event Type  malfunction  

Manufacturer Narrative

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 Description

It was reported that labeling error occurred with a bd vacutainer® urine analysis preservative tube.The following information was provided by the initial reporter, "material no.364992, batch no.8249984.It was reported they received a tube with the wrong labeling.During a new product implementation of custom urine cup kit from aeromed #amm570 with three tubes, uap, c&s, 6ml non additive tube in the er the customer received a yellow top conical bottom tube labeled #364992 ua preservative tube.The tube either came from a ua straw kit #364991 or the amm570.The label does not have a yellow border at the top like our marble top 364992.".

Event Description

It was reported that labeling error occurred with a bd vacutainer® urine analysis preservative tube.The following information was provided by the initial reporter, "material no.364992, batch no.8249984.It was reported they received a tube with the wrong labeling.During a new product implementation of custom urine cup kit from aeromed #amm570 with three tubes, uap, c&s, 6ml non additive tube in the er the customer received a yellow top conical bottom tube labeled #364992 ua preservative tube.The tube either came from a ua straw kit #364991 or the amm570.The label does not have a yellow border at the top like our marble top 364992.".

Manufacturer Narrative

H.6.Investigation: investigation summary: bd had not received samples, but photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for incorrect stopper color with the incident lot was observed.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the customer photos, the customer¿s indicated failure mode for incorrect stopper color with the incident lot was observed.Root cause description: based on the investigation, the most likely root cause was determined to be related to a manufacturing issue.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® URINE ANALYSIS PRESERVATIVE TUBE
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 8557717
• MDR Text Key: 147365822
• Report Number: 1917413-2019-01392
• Device Sequence Number: 1
• Product Code: KDT
• UDI-Device Identifier: 50382903649926
• UDI-Public: 50382903649926
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/20/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/26/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2020
• Device Catalogue Number: 364992
• Device Lot Number: 8249984
• Date Manufacturer Received: 04/04/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other