MAUDE Adverse Event Report: BECTON, DICKINSON & CO., (BD) BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH HOLDER; BLOOD SPECIMEN COLLECTION DEVICE.

Catalog Number	367354
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/16/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).Results: a sample from same lot returned for evaluation, actual device not returned.Bd was not able to confirm or duplicate indicated failure.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 4308832.Conclusion: 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.
Event or Problem Description
It was reported that the needle broke from the rest of the bd vacutainer® safety-lok¿ blood collection set with holder 23 gauge 3/4 inch needle length safety needle 12 inch tubing device while inserting into a patient.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET WITH HOLDER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE.
• Manufacturer (Section D): BECTON, DICKINSON & CO., (BD); 1575 airport road; sumter SC 29153
• MDR Report Key: 7077167
• Report Number: 1024879-2017-00829
• Device Sequence Number: 13678157
• Product Code: JKA
• UDI-Device Identifier: 00382903673544
• UDI-Public: 382903673544
• Combination Product (Y/N): N
• Initial Reporter Country: EI
• PMA/510(K) Number: K030573
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/01/2017

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: 10/31/2016
• Device Catalogue Number: 367354
• Device Lot Number: 4308832
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/07/2016
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/16/2015
• Initial Report FDA Received Date: 12/01/2017
• 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