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	11/09/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.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.The following information was provided by the initial reporter.The customer stated: "there is leaking at the needle while changing tubes.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval: yes.D9: returned to manufacturer on: 2022-11-18.H.6.Investigation summary: h.6.Investigation summary: bd received 5 samples and 3 photos for investigation.The photos were reviewed and the indicated failure mode for leakage with the incident lot was not observed.Two of the photos only show product labeling and the third photo is not clear enough to see any leakage / defects.The customer samples were evaluated by visual examination and 3 of the samples by functional leakage testing and the indicated failure mode for leakage with the incident lot was not observed as all product specifications were met.Additionally, 48 retention samples from bd inventory were evaluated by visual examination and 12 retention samples by functional leakage testing and no issues were observed relating to 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 mode leakage.Bd was not able to identify a root cause for the indicated failure mode.
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.The following information was provided by the initial reporter.The customer stated: "there is leaking at the needle while changing tubes.".

• 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: 15879306
• Report Number: 2618282-2022-00082
• Device Sequence Number: 17504309
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 50382903649025
• Combination Product (Y/N): Y
• Initial Reporter State: SC
• 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): 12/05/2022

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: 06/30/2025
• Device Model Number: 364902
• Device Catalogue Number: 36490200
• Device Lot Number: 2179388
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/09/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 11/29/2022
• Supplement Report FDA Received Date: 12/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2022
• 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