MAUDE Adverse Event Report: BECTON, DICKINSON & CO. BD VACUTAINER® SINGLE USE HOLDER; BLOOD COLLECTION SET

Catalog Number 364815

Device Problem Detachment Of Device Component (1104)

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

Event Date 02/26/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration 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 that the needle of the bd vacutainer® single use holder detached from the holder during use.No reports of serious injury or medical intervention noted.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were tested and the customer's indicated failure mode for separation with the incident lot was not observed as all product specifications were met.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 samples, the customer¿s indicated failure mode for separation with the incident lot was not observed as all samples met the required specifications.Based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.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.

Manufacturer Narrative

Investigation summary: bd received samples from the customer facility for investigation.The samples were tested and the customer's indicated failure mode for separation with the incident lot was not observed as all product specifications were met.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 samples, the customer¿s indicated failure mode for separation with the incident lot was not observed as all samples met the required specifications.Based on the investigation, a root cause could not be determined.The product was found to be in conformance and meet release specifications.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® SINGLE USE HOLDER
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO.; 150 south 1st avenue; broken bow NE 68822
• MDR Report Key: 7332064
• MDR Text Key: 102325818
• Report Number: 1917413-2018-00049
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903648153
• UDI-Public: 00382903648153
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 06/27/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 364815
• Device Lot Number: 7272719
• Date Manufacturer Received: 02/26/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other