MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET

Catalog Number	367352
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/04/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.The manufacturing records were reviewed for the incident lot and no issues were identified.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.Capa (b)(4) has been initiated for documentation related to severed tubing.
Event or Problem Description
It was reported that the bd vacutainer® push button blood collection set is cut in half upon opening the edges.When blood is drawn it is seeping out the edges of the butterfly.No medical intervention or injury reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7100610
• Report Number: 1024879-2017-00916
• Device Sequence Number: 13648839
• Product Code: JKA
• UDI-Device Identifier: 50382903673525
• UDI-Public: 50382903673525
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K030573
• 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): 11/21/2017

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: 04/30/2018
• Device Catalogue Number: 367352
• Device Lot Number: 6126880
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/04/2016
• Initial Report FDA Received Date: 12/08/2017
• 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