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

Catalog Number 364992

Device Problems Short Fill (1575); Volume Accuracy Problem (1675)

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

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 vacutainers are under filling with a bd vacutainer® urine analysis preservative tube.This occurred on 4 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: (1 of 2 complaints) it is reported vacutainers are under filling.Additional information provided by customer: it is not pulling enough urine up into the marble top tubes to go past the minimum fill line and needles have been falling down into the specimen frequently.

Event Description

It was reported that vacutainers are under filling with a bd vacutainer® urine analysis preservative tube.This occurred on 4 separate occasions during use, however, the date/time and or patient information is unknown.The following information was provided by the initial reporter: (1 of 2 complaints) it is reported vacutainers are under filling.Additional information provided by customer: it is not pulling enough urine up into the marble top tubes to go past the minimum fill line and needles have been falling down into the specimen frequently.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.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.Bd has initiated further investigation relating to this issue through capa 1378976.The investigation is still on-going and improvements will be made as the potential causes of this issue are identified.H3 other text : see section h.10.

• 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: 9638598
• MDR Text Key: 188063480
• Report Number: 1917413-2020-00039
• 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: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/28/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2020
• Device Catalogue Number: 364992
• Device Lot Number: 9158860
• Date Manufacturer Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other