MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SERUM TUBES

Catalog Number 367814

Device Problem Detachment Of Device Component (1104)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/09/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device lot #: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.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 after use of the bd vacutainer® serum tubes there was a complaint of the caps popping off.The consumer stated ¿the cap is coming off the tubes.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

The initial mdr reported the lot number as unknown therefore no expiration date or manufacture date was given.The lot number has been identified.Medical device lot number: 7299714.Medical device expiration date: 05/31/2019.Device manufacture date: 10/26/2017.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 decapping with the incident lot was not 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.Based on evaluation of the customer photos, the customer¿s indicated failure mode for decapping with the incident lot was not observed.The photos did not identify a specific product issue.Based on the investigation, a root cause could not be determined.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® SERUM TUBES
• Type of Device: VACUTAINER
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7388877
• MDR Text Key: 104270568
• Report Number: 1024879-2018-00121
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903678148
• UDI-Public: 50382903678148
• Combination Product (y/n): N
• PMA/PMN Number: K901449
• 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: 04/20/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 367814
• Device Lot Number: 7299714
• Date Manufacturer Received: 03/23/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other