MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN); BLOOD COLLECTION TUBE

Catalog Number	365987
Medical Device Problem Code	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/21/2016
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation: 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 gel migration with the incident lot 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.
Event or Problem Description
It was reported that several bd microtainer® pst¿ tubes with lh (lithium heparin) suffered from ¿melted gel¿.Per the customer ¿somehow, 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¿.The specimens required recollections, but there was no report of exposure, injury or medical interventions.

• Brand Name: BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN)
• Common Device Name: BLOOD COLLECTION TUBE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 7434612
• Report Number: 2618282-2018-00320
• Device Sequence Number: 1146581
• Product Code: JKA
• UDI-Device Identifier: 50382903659871
• UDI-Public: 50382903659871
• 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): 04/13/2018

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: 04/30/2017
• Device Catalogue Number: 365987
• Device Lot Number: 603882N
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/25/2016
• Initial Report FDA Received Date: 04/16/2018
• 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