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

Model Number	365965
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/21/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 910158n, medical device expiration date: 2020-09-30, device manufacture date: 2019-04-11.Medical device lot #: 912391n, medical device expiration date: 2020-10-31, device manufacture date: 2019-05-03.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
Material no.365965 batch no.910158n, 912391n.It was reported that during use of the bd microtainer® tubes with lh (lithium heparin) there is decreased co2 results when using bd microtainer tubes.The following information was provided by the initial reporter: customer complained of having decreased co2 results using bd microtainer green top tubes.They are still investigating the cause and have confirmed the issue is not from their reagents.
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for evaluation.Retention samples of the incident lot were selected from bd inventory for evaluation and upon completion, no issues with the tubes were observed.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-conformance's during manufacturing of the product.Instrument company determined was not the microtainer device.
Event or Problem Description
Material no.365965 batch no.910158n, 912391n it was reported that during use of the bd microtainer® tubes with lh (lithium heparin) there is decreased co2 results when using bd microtainer tubes.The following information was provided by the initial reporter: customer complained of having decreased co2 results using bd microtainer green top tubes.They are still investigating the cause and have confirmed the issue is not from their reagents.

• 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: 9306087
• Report Number: 2618282-2019-00281
• Device Sequence Number: 2019482
• Product Code: JKA
• UDI-Device Identifier: 50382903659659
• UDI-Public: 50382903659659
• Combination Product (Y/N): N
• Initial Reporter State: MS
• 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): 02/24/2020

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 Model Number: 365965
• Device Catalogue Number: 365965
• Device Lot Number: SEE H.10
• Initial Date Received by Manufacturer: 10/21/2019
• Supplement Date Received by Manufacturer: 10/21/2019
• Initial Report FDA Received Date: 11/11/2019
• Supplement Report FDA Received Date: 02/24/2020
• 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