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

Catalog Number	365965
Medical Device Problem Code	Coagulation in Device or Device Ingredient (1096)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the sample collected for bilirubin in the bd microtainer® tube with lh (lithium heparin) clotted during use, but was run through the analyzer regardless "with no issues".The following information was provided by the initial reporter: "spoke with customer and they had 2-3 samples that were clotted in the microtainer tubes.They were collected for bilirubin.He feels it is a collection issue by the nurses, that they are not mixing them correctly.Samples were not hemolysed.They did run samples with no issues and have validated the bilirubin test on serum samples.".
Additional Manufacturer Narrative
Investigation: investigation summary: bd had not received samples or photos from the customer facility for evaluation; therefore, the investigation was limited.Retention samples were selected from bd inventory for evaluation/testing and upon completion, no issues were observed relating to clotting as all samples met specifications.A review of the device history record was completed for the incident lot and, based on this review, all product specifications and requirements for lot release were met; there were no related quality non-conformances during manufacturing of the product.Investigation conclusion: based on evaluation of the retain samples, the customer¿s indicated failure mode for clotting with the incident lot was not observed as all samples met the required specifications.Root cause description: based on the investigation, a root cause could not be determined.The retain product was found to be in conformance and meet release specifications.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the sample collected for bilirubin in the bd microtainer® tube with lh (lithium heparin) clotted during use, but was run through the analyzer regardless "with no issues".The following information was provided by the initial reporter: "spoke with customer and they had 2-3 samples that were clotted in the microtainer tubes.They were collected for bilirubin.He feels it is a collection issue by the nurses, that they are not mixing them correctly.Samples were not hemolysed.They did run samples with no issues and have validated the bilirubin test on serum samples.".

• Brand Name: BD MICROTAINER® TUBES WITH LH (LITHIUM HEPARIN)
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• MDR Report Key: 8781572
• Report Number: 2618282-2019-00223
• Device Sequence Number: 13962801
• Product Code: JKA
• UDI-Device Identifier: 50382903659659
• UDI-Public: 50382903659659
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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 Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/01/2019

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: Health Professional
• Device Expiration Date: 04/30/2020
• Device Catalogue Number: 365965
• Device Lot Number: 830556N
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 06/26/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 08/01/2019
• 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