MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS WITH PRE-ATTACHED HOLDER

Catalog Number	367352
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/24/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: bd received three samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for defective plastic molding with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: bd was able to duplicate or confirm the customer¿s indicated failure mode.
Event or Problem Description
It was reported that a bd vacutainer® push button blood collection sets with pre-attached holder had extra, sharp plastic around the beige hub.This was observed from two samples.There is a third sample that has been circled for a plastic molding defect.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SETS WITH PRE-ATTACHED HOLDER
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7085783
• Report Number: 1024879-2017-00309
• Device Sequence Number: 19301336
• Product Code: JKA
• UDI-Device Identifier: 00382903673520
• UDI-Public: 00382903673520
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K011984
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2017

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
• Operator of Device: Other
• Device Expiration Date: 09/30/2017
• Device Catalogue Number: 367352
• Device Lot Number: 5272855
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/27/2016
• Initial Report FDA Received Date: 12/05/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other