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

Catalog Number	36490200
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Exposure to Body Fluids (1745)
Date of Event	11/04/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial reporter email:: (b)(6).Investigation summary: bd had not received samples or photos for investigation.Therefore, 48 retention samples from bd inventory were evaluated by visual examination and 12 retention samples were evaluated by functional leakage testing, and no issues were observed relating to sleeve 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 sleeve 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, the device experienced blood splatter /leakage or other sample leakage from the device other than from the non-patient end needle/sleeve.The following information was provided by the initial reporter.The customer stated: patient 3 of 3 customer confirmed it was 3 individuals affected.Customer states blood flows from device when attaching the vacutainer.
Additional Manufacturer Narrative
The following field needs to be corrected as we were not made aware of the additional patients until 09-nov-2022: g.4.Date received by manufacturer: 09-nov-2022.
Event or Problem Description
It was reported when using the bd luer-lok access device, the device experienced blood splatter /leakage or other sample leakage from the device other than from the non-patient end needle/sleeve.The following information was provided by the initial reporter.The customer stated: patient 3 of 3 customer confirmed it was 3 individuals affected.Customer states blood flows from device when attaching the vacutainer.

• Brand Name: BD LUER-LOK ACCESS DEVICE
• 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: 15954580
• Report Number: 2618282-2022-00090
• Device Sequence Number: 7341478
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 00382903649020
• Combination Product (Y/N): N
• 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): 02/17/2023

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: 06/30/2025
• Device Catalogue Number: 36490200
• Device Lot Number: 2179388
• 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: 11/04/2022
• Supplement Date Received by Manufacturer: 11/09/2022
• Initial Report FDA Received Date: 12/09/2022
• Supplement Report FDA Received Date: 03/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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