MAUDE Adverse Event Report: BD CARIBE LTD. BD LUER-LOK¿ ACCESS DEVICE (MALE LUER); BLOOD SPECIMEN COLLECTION DEVICE

Model Number	364902
Medical Device Problem Codes	Leak/Splash (1354); Product Quality Problem (1506)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/25/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported when using the bd luer-lok¿ access device there was blood leakage or other sample leakage from the device other than the insertion site or needle tip and the hub separated from the device.The leakage event occurred 2 times.The hub separation issue occurred 1 time.The following information was provided by the initial reporter.The customer reported issues of blood leaking from the hub during blood draw x 2 and 1 instance where the hub separated.
Event or Problem Description
It was reported when using the bd luer-lok¿ access device there was blood leakage or other sample leakage from the device other than the insertion site or needle tip and the hub separated from the device.The leakage event occurred 2 times.The hub separation issue occurred 1 time.The following information was provided by the initial reporter.The customer reported issues of blood leaking from the hub during blood draw x 2 and 1 instance where the hub separated.
Additional Manufacturer Narrative
H.6.Investigation summary: "bd had not received samples or photos for investigation.Therefore, 12 retention samples from bd inventory were evaluated by functional leak testing and torque testing and no issues were observed relating to hub separation or leakage as all samples met specifications.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 is unable to be confirmed for the indicated failure modes hub separation and leakage bd was not able to identify a root cause for the indicated failure mode.".

• Brand Name: BD LUER-LOK¿ ACCESS DEVICE (MALE LUER)
• 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: 16936382
• Report Number: 2618282-2023-00035
• Device Sequence Number: 12195096
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 50382903649025
• Combination Product (Y/N): N
• Initial Reporter State: WA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/12/2023

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: Other
• Device Expiration Date: 08/31/2025
• Device Model Number: 364902
• Device Catalogue Number: 36490200
• Device Lot Number: 2238442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/25/2023
• Supplement Date Received by Manufacturer: 06/12/2023
• Initial Report FDA Received Date: 05/15/2023
• Supplement Report FDA Received Date: 06/14/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/11/2022
• 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