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

Catalog Number 36490200

Device Problem Leak/Splash (1354)

Patient Problem Exposure to Body Fluids (1745)

Event Date 11/04/2022

Event Type  malfunction  

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 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 2 of 3 customer confirmed it was 3 individuals affected.Customer states blood flows from device when attaching the vacutainer.

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 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 2 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
• Type of Device: 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: 15945676
• MDR Text Key: 306178657
• Report Number: 2618282-2022-00089
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 50382903649025
• UDI-Public: 00382903649020
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 36490200
• Device Lot Number: 2179388
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1