MAUDE Adverse Event Report: BECTON, DICKINSON AND COMPANY (BD) BD VACUTAINER® MULTI SAMPLE BLOOD COLLECTION NEEDLE; BLOOD COLLECTION SET

Catalog Number 360213

Device Problem Air Leak (1008)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/06/2017

Event Type  malfunction  

Manufacturer Narrative

Results - results bd received samples and photos from the customer facility for investigation.The samples and photos were evaluated and the customer¿s indicated failure mode for an air leak with the incident lot was observed.Conclusion - the root cause of this defect has been identified as most likely to be a manufacturing defect when the cannula was being formed.

Event Description

It was reported that a bd vacutainer® multi sample blood collection needle had an air leak which caused blood collection to stop.No injury or medical intervention reported.

Manufacturer Narrative

Additional information: a dhr review was conducted.Dhr/bhr review: no qns or other issues relating to the reported defect were identified in the dhr.

• Brand Name: BD VACUTAINER® MULTI SAMPLE BLOOD COLLECTION NEEDLE
• Type of Device: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer (Section G): BECTON, DICKINSON AND COMPANY (BD); belliver way; belliver industrial estate; plymouth
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7088676
• MDR Text Key: 94805644
• Report Number: 9617032-2017-00633
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/06/2018

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: 06/30/2021
• Device Catalogue Number: 360213
• Device Lot Number: 6174906
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/15/2017
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/10/2017
• Initial Date FDA Received: 12/06/2017
• Supplement Dates Manufacturer Received: 03/10/2017
• Supplement Dates FDA Received: 03/07/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/22/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other