MAUDE Adverse Event Report: BD CARIBE LTD. SEE H.10; BLOOD SPECIMEN COLLECTION DEVICE

Catalog Number 36490200

Device Problems Fluid/Blood Leak (1250); Product Quality Problem (1506)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/03/2024

Event Type  malfunction  

Manufacturer Narrative

D1.Medical device brand name: bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter.H.6.Investigation summary: material #: 36490200.Lot/batch #: 3107068.Bd had not received samples, but 4 photos were provided for investigation.The photos were reviewed and the indicated failure mode for broken luer hub was observed.Additionally, 48 retention samples from bd inventory were evaluated by visual examination and another 12 by functional testing and the issue of broken luer hub 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 broken luer hub.Bd was not able to identify a root cause for the indicated failure mode.

Event Description

It was reported that while using bd vacutainer® luer-lok¿ access device holder with pre-attached multiple sample adapter, the hub separated from one (1) device resulting in blood leakage.No patient impact or blood exposure reported.

• Brand Name: SEE H.10
• Type of Device: 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: jo doyka ; 7 loveton circle; sparks, MD 21152 ; 4103164000
• MDR Report Key: 19014987
• MDR Text Key: 339105897
• Report Number: 2618282-2024-00020
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903649020
• UDI-Public: (01)00382903649020
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K991088
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/19/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 36490200
• Device Lot Number: 3107068
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/06/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/30/2023
• 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