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

Catalog Number	365987
Medical Device Problem Code	Device Ingredient or Reagent Problem (2910)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/29/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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) - amber, 1 tube contained liquid gel.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.H3: device eval by manufacturer? yes.D9: returned to manufacturer on: 13-may-2025.Investigation summary: bd received 1 sample for investigation.The customer sample was evaluated for barrier gel characteristics and presence of additive.Presence of additive was found acceptable; however, barrier gel smear was observed on the sample.Additionally, fifty (50) retention samples were evaluated for barrier gel characteristics and presence of additive with acceptable results.Based on a review of the device history record for the incident lot, all product specifications and requirements for lot release were met.There were no related quality issues during manufacturing of the product.This complaint has been confirmed for gel smearing based on the return sample received.No additive issue was observed.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.
Event or Problem Description
It was reported prior to use of bd microtainer® pst¿ tubes with lh (lithium heparin): amber, 1 tube contained liquid gel.There was no health impact or consequences reported.

• Brand Name: BD MICROTAINER® PST¿ TUBES WITH LH (LITHIUM HEPARIN) - AMBER
• 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: 22097287
• Report Number: 2618282-2025-00043
• Device Sequence Number: 7357460
• Product Code: JKA
• UDI-Device Identifier: 30382903659877
• UDI-Public: (01)30382903659877(11)241206(17)260228(10)434107N
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/30/2025

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: 02/28/2026
• Device Catalogue Number: 365987
• Device Lot Number: 434107N
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 05/29/2025
• Initial Report FDA Received Date: 05/28/2025
• Supplement Report FDA Received Date: 06/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/06/2024
• 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