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

Catalog Number 36490200

Device Problem Separation Failure (2547)

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

Event Date 04/06/2022

Event Type  malfunction  

Manufacturer Narrative

H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that while using bd luer-lok access device, the tube got stuck in the holder.Three staff tried to remove it but couldn't, hemostats had to be placed on the device to separate it.No report of adverse or injury.

Event Description

It was reported that while using bd luer-lok access device, the tube got stuck in the holder.Three staff tried to remove it but couldn't, hemostats had to be placed on the device to separate it.No report of adverse or injury.

Manufacturer Narrative

H.6.Investigation summary: material #: 36490200.Lot/batch #: unknown.Bd had not received samples or photos for evaluation.Additionally, bd was unable to determine the specific lot number associated with this complaint; therefore, a review of the device history record could not be conducted.This complaint is unable to be confirmed.If additional information is made available, this complaint will be reopened to assess the level of investigation needed.

• 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 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: 18134642
• MDR Text Key: 328135202
• Report Number: 2618282-2023-00101
• Device Sequence Number: 1
• Product Code: JKA
• UDI-Device Identifier: 00382903649020
• UDI-Public: (01)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: 11/17/2023

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
• Device Operator: Other
• Device Catalogue Number: 36490200
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/16/2023
• Initial Date FDA Received: 11/14/2023
• Supplement Dates Manufacturer Received: 11/17/2023
• Supplement Dates FDA Received: 11/30/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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