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

Model Number 364951

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/21/2021

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.(b)(4).

Event Description

It was reported the bd vacutainer¿ c&s preservative urine tube experienced underfill or low draw.The following information was provided by the initial reporter.The customer stated: "after studying our recollection data since december, our number of recollects for gray top urine tubes being underfilled has increased (from 1-2 per month to 10-15 per month).No harm or injury.".

Event Description

It was reported the bd vacutainer® c&s preservative urine tube experienced underfill or low draw.The following information was provided by the initial reporter.The customer stated: "after studying our recollection data since december, our number of recollects for gray top urine tubes being underfilled has increased (from 1-2 per month to 10-15 per month).No harm or injury.".

Manufacturer Narrative

H.6.Investigation: bd had not received samples or photos for evaluation.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.Bd was not able to identify a root cause for the indicated failure mode.H3 other text : see h.10.

• Brand Name: BD VACUTAINER C&S PRESERVATIVE URINE TUBE
• Type of Device: TRANSPORT CULTURE MEDIUM
• Manufacturer (Section D): BECTON, DICKINSON & CO. (BROKEN BOW); 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 11308469
• MDR Text Key: 231351967
• Report Number: 1917413-2021-00082
• Device Sequence Number: 1
• Product Code: JSM
• UDI-Device Identifier: 50382903649513
• UDI-Public: 50382903649513
• Combination Product (y/n): N
• PMA/PMN Number: K024240
• 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: 02/11/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/10/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/31/2022
• Device Model Number: 364951
• Device Catalogue Number: 364951
• Device Lot Number: 0253764
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/11/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1