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

Catalog Number 1022-156-032

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

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

Event Date 01/10/2023

Event Type  malfunction  

Event Description

It was reported that foreign matter was found in 1 bd luer-lock¿ female adaptor from lot: 2017557, and 2 adaptors from lot :2256443.The following information was provided by the initial reporter: "dirt".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is us molding coe.This site is an oem manufacturing site.Therefore, bd corporate headquarters in franklin lakes, nj has been listed in manufacturer name, city and state and mfr site and the franklin lakes fda registration number has been used for the manufacture report number.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot#: 2017557, medical device expiration date: na, device manufacture date: 17-jan-2022, medical device lot#: 2256443, medical device expiration date: na, device manufacture date: 13-sep-2022.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

H6: investigation summary: a complaint of dirt on the component was received from the customer.A photo was provided for investigation, but the image does not display any foreign matter.Samples have not been provided, so the defect cannot be confirmed.From the dhr review of lot number 2256443 and 2017557, there was no recorded activity associated with this condition.

Event Description

It was reported that foreign matter was found in 1 bd luer-lock¿ female adaptor from lot 2017557, and 2 adaptors from lot 2256443.The following information was provided by the initial reporter: "dirt".

• Brand Name: BD LUER-LOCK¿ FEMALE ADAPTOR
• 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: 16345073
• MDR Text Key: 309561429
• Report Number: 2243072-2023-00170
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/22/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/09/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1022-156-032
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2023
• 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