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

Catalog Number	367352
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/02/2016
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 photos were provided by the customer facility for investigation.The photos were evaluated and the customer's indicated failure mode for severed tubing with the incident lot was observed.As this is a confirmed complaint, a dhr review is not required.Refer to capa (b)(4) for complete documentation and action plans.Conclusion: confirmed complaint.(b)(4) has been initiated to document the investigation path, root cause analysis and remediation plan to include corrective and preventive actions.
Event or Problem Description
It was reported that a crimp in between the needle and holder, caused the tubing of the bd vacutainer® ultratouch¿ push button blood collection set to break apart during a phlebotomy procedure.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® ULTRATOUCH¿ PUSH BUTTON BLOOD COLLECTION SET
• Common Device Name: BLOOD SPECIMEN COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7064758
• Report Number: 1024879-2017-00366
• Device Sequence Number: 16174601
• Product Code: JKA
• UDI-Device Identifier: 00382903673520
• UDI-Public: 00382903673520
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 10/27/2017

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: 01/31/2018
• Device Catalogue Number: 367352
• Device Lot Number: 6021869
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/02/2016
• Initial Report FDA Received Date: 11/28/2017
• 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