MAUDE Adverse Event Report: BD CARIBE LTD. BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN); TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION

Catalog Number	365985
Medical Device Problem Code	Incorrect, Inadequate or Imprecise Result or Readings (1535)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter facility name: (b)(6) hospital.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported prior to use of bd microtainer® pst¿ tubes with lh (lithium heparin), the additive was stuck to the top in an unspecified number tubes.There was no health impact or consequences reported.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for evaluation: yes.H.3 device eval by manufacturer? yes.D9: returned to manufacturer on: 24-dec-2024.Investigation summary: bd received a sample and two (2) photos for investigation.The sample and photos were reviewed and the indicated failure mode for gel smearing was observed.Additionally, fifty (50) retention samples from bd inventory, were evaluated by visual examination and the issue of gel smearing was not observed.Complaints for sample quality are under statistical control for the month of november 2024.At this time, further testing is not indicated.The batch history review was satisfactory per internal procedures.This complaint has been confirmed for the indicated failure mode of gel smearing.Bd was not able to identify a root cause for the indicated failure mode.Complaints received for this device and reported condition will continue to be tracked and trended.Our business team regularly reviews the collected data for identification of emerging trends.Bd quality will continue to monitor sample quality complaints.
Event or Problem Description
It was reported prior to use of bd microtainer® pst¿ tubes with lh (lithium heparin), the additive was stuck to the top in an unspecified number tubes.There was no health impact or consequences reported.

• Brand Name: BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN)
• Common Device Name: TUBES, VIALS, SYSTEMS, SERUM SEPARATORS, BLOOD COLLECTION
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos PR
• Manufacturer Contact: matt j. connor ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 20871299
• Report Number: 2618282-2024-00182
• Device Sequence Number: 20973599
• Product Code: JKA
• UDI-Device Identifier: 30382903659853
• UDI-Public: (01)30382903659853(11)240321(17)250630(10)408133N
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K991702
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/08/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2025
• Device Catalogue Number: 365985
• Device Lot Number: 408133N
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/15/2024
• Supplement Date Received by Manufacturer: 02/05/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 02/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown