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

Catalog Number	367352
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/14/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Results: bd had not received samples but four (4) photos were received from the customer facility for investigation.Based on the visual inspection/evaluation of the photos, bd observed sliced tubing, a hole in the holder, and a device with a spring protruding from the barrel.Conclusion: an absolute root cause has not be identified.Capa (b)(4) was initiated to determine root cause and implement corrective actions in order to reduce/mitigate further occurrence of this issue.
Event or Problem Description
It was reported that the tubing of the bd vacutainer® push button blood collection set was leaking.Another set had a hole in the holder and another set holder was damaged.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7115463
• Report Number: 1024879-2017-00918
• Device Sequence Number: 1629555
• Product Code: JKA
• UDI-Device Identifier: 50382903673525
• UDI-Public: 50382903673525
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): 12/13/2017

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: 07/31/2018
• Device Catalogue Number: 367352
• Device Lot Number: 6202832
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/14/2016
• Initial Report FDA Received Date: 12/13/2017
• 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