MAUDE Adverse Event Report: BECTON DICKINSON BD LUER-LOCK¿ FEMALE ADAPTER; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 1022-130-032

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 08/18/2022

Event Type  malfunction  

Event Description

It was reported that foreign matter was found in the luer of the bd luer-lock¿ female adapter.The following information was provided by the initial reporter: "defect - debris in luer thru hole".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, (b)(4).Medical device expiration date: na.Investigation summary: a complaint of foreign matter being found inside a luer was received from the customer.Photos were provided for investigation where a clear material could be seen inside the luer hole.A device history review was performed for lot#: 2041965 and no quality notifications were opened at namc related to this condition.An investigation was performed that indicated this condition could occur due to a partially broken pin or flash around the core due to a bad shut off generated by a damage pin.Since no physical samples were available for review at namc, and no cavity numbers were provided, the defect could not be confirmed.Additionally, it is unlikely to be a tooling related flash due to the geometry displayed on the defective image.Furthermore, from the mold preventative maintenance record, there is no indication of this condition being present at namc.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.

• Brand Name: BD LUER-LOCK¿ FEMALE ADAPTER
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15407166
• MDR Text Key: 306425528
• Report Number: 2243072-2022-01490
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/20/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/12/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1022-130-032
• Device Lot Number: 2041965
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/10/2022
• 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