MAUDE Adverse Event Report: BECTON DICKINSON BD¿ MALE ADAPTOR; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 1102-173-004

Device Problem Defective Component (2292)

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

Event Date 01/28/2021

Event Type  malfunction  

Event Description

It was reported that 10 bd¿ male adaptors had molding defects found prior to use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "during customer use, it was detected twenty (20) units of material 03-26-50-052 (male luer lock, clnd adaptor) with "short shot"."there was no impact to patient, medical intervention, or exposure to blood either.The incident was noticed prior use.".

Manufacturer Narrative

Oem manufacturer: the manufacturing location for this product is (b)(4).This site is an oem manufacturing site.Therefore, bd corporate headquarters in (b)(4) has been listed and (b)(4) fda registration number has been used for the manufacture report number.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 10 bd¿ male adaptors had molding defects found prior to use.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "during customer use, it was detected twenty (20) units of material 03-26-50-052 (male luer lock, clnd adaptor) with "short shot"." "there was no impact to patient, medical intervention, or exposure to blood either.The incident was noticed prior use.".

Manufacturer Narrative

H6: investigation summary a complaint of (b)(4) units with a short shot issue were received from the customer.Two photos were received from the customer.In one photo a defect can be seen on the male luer.The second photo shows the other side of the male luer.An investigation was performed by the manufacturing site.A historical review of this part code was performed with no instances of short shot reported for this product code at the namc.There were no non-conformances reported for short shots on the lots reported in this complaint.Lot 0302012 was manufactured on 13dec2020 and (b)(4) parts were visually inspected with no defects noted.Lot 1004919 was manufactured on 16jan2021 and (b)(4) parts were visually inspected with no defects noted.A root cause could not be determined as a physical sample was not received for investigation.H3 other text : see h10.

• Brand Name: BD¿ MALE 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12819839
• MDR Text Key: 286643859
• Report Number: 2243072-2021-02718
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: DR
• 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: 01/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1102-173-004
• Device Lot Number: 0302012
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/23/2020
• 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