MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® PST AMBER TUBES; BLOOD COLLECTION TUBE

Catalog Number	365987
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/06/2015
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 received samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for no gel with the incident lot was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Conclusion: per customer sample evaluation the reported condition was confirmed.The barrier gel station, qualified in august 2014, has a vision system that performs 100% inspection for the presence of barrier gel.In addition, an improvement in the vision system was implemented via validation in october 2014 to further increase presence of barrier gel detectability.
Event or Problem Description
It was reported that bd microtainer® pst amber tubes had no gel in the tube.No injury or medical intervention reported.

• Brand Name: BD MICROTAINER® PST AMBER TUBES
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7099596
• Report Number: 2618282-2017-00039
• Device Sequence Number: 1131322
• Product Code: JKA
• UDI-Device Identifier: 00382903659876
• UDI-Public: 00382903659876
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K991702
• 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): 11/17/2017

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: 12/31/2015
• Device Catalogue Number: 365987
• Device Lot Number: 429019N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/22/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/06/2015
• Initial Report FDA Received Date: 12/08/2017
• 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