MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ MINI PEN NEEDLES; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320882

Device Problem Failure to Prime (1492)

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

Event Date 11/21/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 the bd ultra-fine¿ mini pen needles was unable to prime.The following information was provided by the initial reporter: consumer reported needle clog during priming.

Event Description

It was reported that the bd ultra-fine¿ mini pen needles was unable to prime.The following information was provided by the initial reporter: consumer reported needle clog during priming.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 03-jan-2023.H6: investigation summary customer returned one pen needle 31g 5mm.Customer reported that needle does not attach as intended.The needle was visually inspected and found bent on the non-patient end.Based on the damage review the needles bent may have occurred accidently, while the user was preparing the pen needle for use.Potentially if the pen was not aligned with the canula which could make the needle to bent.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.Based on the sample received, embecta was able to confirm the customer indicated failure.The root cause of the needles bent appears to be accidental damage from stresses caused by the user during routine use.

• Brand Name: BD ULTRA-FINE¿ MINI PEN NEEDLES
• 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: 15963167
• MDR Text Key: 307928925
• Report Number: 9616656-2022-01357
• Device Sequence Number: 1
• Product Code: FRN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K213478
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 02/27/2023

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: Lay User/Patient
• Device Catalogue Number: 320882
• Device Lot Number: 1278347
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Initial Date Manufacturer Received: 11/21/2022
• Initial Date FDA Received: 12/12/2022
• Supplement Dates Manufacturer Received: 02/27/2023
• Supplement Dates FDA Received: 03/09/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/05/2021
• 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