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

Model Number	364902
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/14/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 (male luer), there was blood leakage or other sample leakage from the device other than the insertion site or needle tip.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "whilst collecting a patient sample, the llad was leaking from the 18g needle inside the holder where the blood tubes are inserted.Customer collected 2-3 blood tubes and not sure whether this is caused by user error or the llad is leaking.She did note this has happened in 2 separate patients and could be a device error.
Additional Manufacturer Narrative
H.6.Investigation summary: bd had not received samples, but 3 photos were provided for investigation.The photos were reviewed and the indicated failure mode for leakage was observed.Additionally, 48 retention samples from bd inventory were evaluated by visual examination and 12 retention samples by functional 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.H3 other text : see h.10.
Event or Problem Description
It was reported when using the bd luer-lok¿ access device (male luer) there was blood leakage or other sample leakage from the device other than the insertion site or needle tip.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "whilst collecting a patient sample the llad was leaking from the 18g needle inside the holder where the blood tubes are inserted.Customer collected 2-3 blood tubes and not sure whether this is caused by user error or the llad is leaking.She did note this has happened in 2 separate patients and could be a device error.

• 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
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15635251
• Report Number: 2618282-2022-00068
• Device Sequence Number: 12391753
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 50382903649025
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/20/2022

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: 06/30/2024
• Device Model Number: 364902
• Device Catalogue Number: 36490200
• Device Lot Number: 1174286
• 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: 10/14/2022
• Supplement Date Received by Manufacturer: 10/20/2022
• Initial Report FDA Received Date: 10/19/2022
• Supplement Report FDA Received Date: 10/26/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/26/2021
• 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