MAUDE Adverse Event Report: BECTON DICKINSON BD SAFE-CLIP¿; HYPODERMIC SINGLE LUMEN NEEDLE

Model Number 328235

Device Problem Failure to Cut (2587)

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

Event Date 12/06/2022

Event Type  malfunction  

Manufacturer Narrative

The manufacturing location for this product is nypro.This site is an oem manufacturing site.Therefore, (b)(4).Medical device expiration date: na.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd safe-clip¿ it was not clipping properly.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: a follow-up call is made to the patient's attendant where the attendant reports that "i think the needle cutter does not cut the needle, but only bends it and it will be that they can send me another one" re-training is scheduled to validate the device's operation.In connection via teams, a needle cutting exercise is carried out and it is evident that the needle cutter does not cut itself, it is evidence of rust in the hole where the needle enters.Recommendations are given on the correct use and storage of the device.

Manufacturer Narrative

H6: investigation summary customer returned a video of a safeclip pen needle cutter.The user struggles to properly insert the pen needle into the needle cutting port.Visual inspection of the safeclip found some degree of deformation around the cutting port.Inserting a test pen needle may not have been possible due to wear and/or material inside the safeclip port.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¿s indicated failure of the safeclip being unable to cut pen needles.The most likely root cause of the safeclip not cutting pen needles is significant wear and tear due to use over time.H3 other text : see h10.

Event Description

It was reported while using bd safe-clip¿ it was not clipping properly.There was no report of patient impact.The following information was provided by the initial reporter, translated from spanish to english: a follow-up call is made to the patient's attendant where the attendant reports that "i think the needle cutter does not cut the needle, but only bends it and it will be that they can send me another one" re-training is scheduled to validate the device's operation.In connection via teams, a needle cutting exercise is carried out and it is evident that the needle cutter does not cut itself, it is evidence of rust in the hole where the needle enters.Recommendations are given on the correct use and storage of the device.

• Brand Name: BD SAFE-CLIP¿
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• 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: 16038391
• MDR Text Key: 308382668
• Report Number: 2243072-2022-02215
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: CO
• PMA/PMN Number: K943683
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/17/2023

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: Other
• Device Model Number: 328235
• Device Catalogue Number: 328235
• Device Lot Number: 2047001
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2022
• Initial Date FDA Received: 12/22/2022
• Supplement Dates Manufacturer Received: 01/17/2023
• Supplement Dates FDA Received: 01/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/17/2022
• 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