MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® WITH LITHIUM HEPARIN AND PLASMA SEPARATOR ADDITIVE; BLOOD COLLECTION TUBE

Catalog Number	365987
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/08/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Results: bd received two samples from the customer facility for investigation.The samples were evaluated and the customer's indicated failure mode for gel on the top of the tube with the incident lot was observed.Additionally, retention samples were selected for evaluation and upon test completion, the customer's indicated failure mode for gel on the top of the tube was observed.A review of the manufacturing records was completed for the incident lot and no issues were identified.Bd has initiated a capa to document further investigation and root cause(s) of this product issue.Conclusion: an absolute root cause for this incident can't be determined based on the investigation.Refer to capa (b)(4).
Event or Problem Description
It was reported that a bd microtainer® with lithium heparin and plasma separator additive had "melted gel".The gel separator has gone to the top of some unused tubes, into the lid, and made its way around the top scoop part of the tube including the outside surface.There was no report of serious injury or medical intervention.

• Brand Name: BD MICROTAINER® WITH LITHIUM HEPARIN AND PLASMA SEPARATOR ADDITIVE
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7100775
• Report Number: 2243072-2017-00345
• Device Sequence Number: 19141105
• Product Code: JKA
• UDI-Device Identifier: 00382903659876
• UDI-Public: 00382903659876
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K991702
• 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): 11/22/2017

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: 06/30/2016
• Device Catalogue Number: 365987
• Device Lot Number: 509978N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/23/2015
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/08/2015
• 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