MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE¿+ PEN NEEDLES 31G X 6MM (100 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320743

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 10/11/2022

Event Type  malfunction  

Event Description

It was reported while using bd micro-fine¿+ pen needles 31g x 6mm (100 count) the cap did not attach properly.There was no report of patient impact.The following information was provided by the initial reporter, translated from (b)(6) to english: the needle caps is compromising the correct closure on the needle.So much so that if it falls on the floor, the plastic cap, the orange plastic cap and needle separate.

Manufacturer Narrative

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

Manufacturer Narrative

H6: investigation summary no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed as per the applicable operations and met qc specifications.

Event Description

It was reported while using bd micro-fine¿+ pen needles 31g x 6mm (100 count) the cap did not attach properly.There was no report of patient impact.The following information was provided by the initial reporter, translated from italian to english: the needle caps is compromising the correct closure on the needle.So much so that if it falls on the floor, the plastic cap, the orange plastic cap and needle separate.

• Brand Name: BD MICRO-FINE¿+ PEN NEEDLES 31G X 6MM (100 COUNT)
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15747444
• MDR Text Key: 303810748
• Report Number: 9616656-2022-01204
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 11/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/07/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 320743
• Device Lot Number: 1040259
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 11/17/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/09/2021
• 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