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

Catalog Number	367352
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
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: photos were inspected showing reported defect.No samples were received for evaluation.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 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 the bd vacutainer® ultratouch¿ push button blood collection set had a hole in the tubing between the needle and holder causing blood spray 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 COLLECTION SET
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7064268
• Report Number: 1024879-2017-00364
• Device Sequence Number: 156043
• 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: Phlebotomist
• 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: Phlebotomist
• Device Expiration Date: 01/31/2018
• Device Catalogue Number: 367352
• Device Lot Number: 6021896
• 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