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	Incorrect Or Inadequate Test Results (2456)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/21/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: bd had not received samples or photos from the customer facility for investigation.Bd was unable to determine the specific lot number associated with this complaint.Therefore, a review of the device history record could not be conducted.Investigation conclusion: this complaint investigation was handled under the premise of a previously investigated issue specific for hemolysis, where it was determined that the results and conclusions established in the previous investigations pointed to the same indicated failure mode and root causes observed in the current complaint investigation.Additionally, the conclusion drawn from the current complaint investigation did not yield new information regarding the indicated failure mode.Complaint data for this failure mode is monitored and trended on a routine basis.Root cause description: this complaint investigation was handled under the premise of a previously investigated issue specific for hemolysis, where it was determined that the results and conclusions established in the previous investigations pointed to the same indicated failure mode and root causes observed in the current complaint investigation.Additionally, the conclusion drawn from the current complaint investigation did not yield new information regarding the indicated failure mode.Complaint data for this failure mode is monitored and trended on a routine basis.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 bd microtainer® tubes with lh (lithium heparin) had hemolysis.No serious injury or medical intervention.No report of blood exposure to mucous membrane.

• 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: 7603559
• Report Number: 2618282-2018-00515
• Device Sequence Number: 1774978
• Product Code: JKA
• UDI-Device Identifier: 50382903659659
• UDI-Public: 50382903659659
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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): 05/11/2018

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: 03/21/2018
• Device Catalogue Number: 365965
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/21/2018
• Initial Report FDA Received Date: 06/14/2018
• 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