MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® URINE COLLECTION CUP; SPECIMEN TRANSPORT & STORAGE CONTAINER

Catalog Number 364941

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Patient Involvement (2645)

Event Date 11/25/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd vacutainer® urine collection cup was clouded.This occurred on 48000 occasions before use.The following information was provided by the initial reporter: urine cup plastic is clouded, not clear plastic.

Event Description

It was reported that bd vacutainer® urine collection cup was clouded.This occurred on 48000 occasions before use.The following information was provided by the initial reporter: urine cup plastic is clouded, not clear plastic.

Manufacturer Narrative

H.6.Investigation summary: bd had not received samples or photos from the customer facility for evaluation.However, results from a clinical study indicated that cups manufactured with a cloudy appearance demonstrated no statistically significant differences for numeric routine urinalysis parameters when compared to other cups manufactured with a clear appearance.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.

• Brand Name: BD VACUTAINER® URINE COLLECTION CUP
• Type of Device: SPECIMEN TRANSPORT & STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 9444857
• MDR Text Key: 188090869
• Report Number: 9617032-2019-01422
• Device Sequence Number: 1
• Product Code: NNK
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 01/27/2020

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
• Device Operator: Other
• Device Expiration Date: 10/31/2021
• Device Catalogue Number: 364941
• Device Lot Number: 9302049
• Initial Date Manufacturer Received: 11/25/2019
• Initial Date FDA Received: 12/10/2019
• Supplement Dates Manufacturer Received: 11/25/2019
• Supplement Dates FDA Received: 01/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other