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

Catalog Number	367352
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	02/25/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Results: a sample was returned for evaluation.The photos showed cut tubing a review of the device history record revealed no irregularities during the manufacture of the reported lot #5314743.Conclusion: root cause was determined to be multivac knives cutting into blister packages and product during sealing process.Refer to capa (b)(4).
Event or Problem Description
It was reported that 21 g x.75 in.Bd vacutainer® push button blood collection set with 12 in.Tubing and pre-attached holder has defective tubing.The tubing that attaches from the needle to the holder has either, the tubing sliced in half, the hose smashed in middle or the blood flows out of the tubing when drawing from patient.There was no report of injury or medical intervention.

• 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: 7059023
• Report Number: 1024879-2017-00808
• Device Sequence Number: 13648879
• Product Code: JKA
• UDI-Device Identifier: 00382903673520
• UDI-Public: 00382903673520
• Combination Product (Y/N): N
• Initial Reporter State: NY
• 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): 10/30/2017

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: 11/30/2017
• Device Catalogue Number: 367352
• Device Lot Number: 5314743
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/10/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2016
• Initial Report FDA Received Date: 11/27/2017
• 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