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

Catalog Number 364941

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/03/2021

Event Type  malfunction  

Manufacturer Narrative

Multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0279497.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 when using the bd vacutainer® urine collection cup there were complaints of sterility issues (product not sterile).Occurred 7 times with lot number: 0279497.Occurred 3 times with lot number: 20349651.The following information was provided by the initial reporter: translated to english.The customer stated: found opened cups in the delivered boxes.One container has urine aspiration device detached at the moment of aspiration.Lack of sterility of the containers, screw cap unscrewed.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 2/10/2021.H.6.Investigation: bd received samples and photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for incorrect placement of label with the incident lot was observed.Additionally, the customer samples were evaluated by visual examination and the indicated failure mode for open package/cup with the incident lot was observed.The most likely root cause for the reported defect is a short term in alignment issue.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.

Event Description

It was reported when using the bd vacutainer® urine collection cup there were complaints of sterility issues (product not sterile).Occurred 7 times with lot number: 0279497.Occurred 3 times with lot number: 20349651.The following information was provided by the initial reporter: translated to english.The customer stated: found opened cups in the delivered boxes.One container has urine aspiration device detached at the moment of aspiration.Lack of sterility of the containers, screw cap unscrewed.

• Brand Name: BD VACUTAINER URINE COLLECTION CUP
• Type of Device: SPECIMEN TRANSPORT AND STORAGE CONTAINER
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth ; UK
• MDR Report Key: 11376341
• MDR Text Key: 250177763
• Report Number: 9617032-2021-00162
• Device Sequence Number: 1
• Product Code: KDT
• Combination Product (y/n): N
• PMA/PMN Number: NA
• 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: 02/26/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/24/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 364941
• Device Lot Number: 20349651
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/10/2021
• Date Manufacturer Received: 02/26/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1