MAUDE Adverse Event Report: BD CARIBE LTD. BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED ADAPTER; BLOOD SPECIMEN COLLECTION DEVICE

Model Number	364902
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/24/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.6.Investigation summary: bd received 7 samples and 2 photos for investigation.The photos were reviewed and the customer¿s indicated failure mode for leakage was observed.Four of the customer samples were observed to have blood remnants inside the holder.The 3 unused customer samples were evaluated by functional leakage testing and the indicated failure mode for leakage with the incident lot was not observed.Additionally, 48 retention samples from bd inventory were evaluated by visual examination and another 12 by functional leakage testing and the issue of leakage was not observed.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 the indicated failure mode leakage.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 that there was blood spillage/leaks from the bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter.Verbatim: having an issue of blood spillage/leaks from the blue top will be visiting the account tomorrow for troubleshooting.

• Brand Name: BD VACUTAINER® LUER-LOK¿ ACCESS DEVICE HOLDER WITH PRE-ATTACHED ADAPTER
• Common Device Name: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17159708
• Report Number: 2618282-2023-00046
• Device Sequence Number: 5745118
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 50382903649025
• Combination Product (Y/N): N
• Initial Reporter Country: TC
• PMA/510(K) Number: K991088
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,User Facility
• Initial Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date (Section B): 05/31/2023

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: Health Professional
• Device Expiration Date: 08/31/2025
• Device Model Number: 364902
• Device Catalogue Number: 36490200
• Device Lot Number: 2243459
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2023
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/24/2023
• Initial Report FDA Received Date: 06/19/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/21/2022
• 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