MAUDE Adverse Event Report: BECTON DICKINSON BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET

Catalog Number	367296
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/22/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.Device manufacture date: unknown.Lot#: 6j1582 also affected.Medical device expiration date: unknown.Device manufacture date: unknown.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 leakage with the incident lot was not observed.Additionally, retention samples were selected for evaluation, and the customer's indicated failure mode for leakage was not observed as all samples met specifications.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: based on the investigation, a root cause could not be determined within the scope of this evaluation.Without a sample bd was unable to duplicate or confirm the customer's indicated failure mode.
Event or Problem Description
It was reported that the bd vacutainer® safety-lok¿ blood collection set leaked blood.No serious injury or medical intervention reported.

• Brand Name: BD VACUTAINER® SAFETY-LOK¿ BLOOD COLLECTION SET
• Common Device Name: BLOOD COLLECTION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 7098077
• Report Number: 2243072-2017-00285
• Device Sequence Number: 1298014
• Product Code: JKA
• UDI-Device Identifier: 50382903672962
• UDI-Public: 50382903672962
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K980414
• 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): 11/20/2017

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 Catalogue Number: 367296
• Device Lot Number: 6G1781
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/22/2017
• Initial Report FDA Received Date: 12/07/2017
• 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