MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD MICRO-FINE ULTRA¿ PRO PEN NEEDLES 32G X 4MM (100 COUNT); HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320562

Device Problem Failure to Deliver (2338)

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

Event Date 08/02/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event is unknown; awareness date has been used for this field.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 micro-fine ultra¿ pro pen needles 32g x 4mm (100 count) the medication could not be properly passed.There was no report of patient impact.The following information was provided by the initial reporter: indeed, the nurse has a problem to pass the insulin to her patient.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 14-sep-2022.H6: investigation summary fifty seven sealed 32g x 4mm pen needle samples were returned from lot.No.1350739, cat.No.320562.A functionality test was carried out on thirty samples as per q-sop-183-dl and no issues were observed.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.No issues were observed with the returned samples therefore no root cause can be identified.

Event Description

It was reported while using bd micro-fine ultra¿ pro pen needles 32g x 4mm (100 count) the medication could not be properly passed.There was no report of patient impact.The following information was provided by the initial reporter: indeed, the nurse has a problem to pass the insulin to her patient.

• Brand Name: BD MICRO-FINE ULTRA¿ PRO PEN NEEDLES 32G X 4MM (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: 15306544
• MDR Text Key: 302594997
• Report Number: 9616656-2022-00915
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• 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: 09/18/2022

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 Catalogue Number: 320562
• Device Lot Number: 1350739
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 08/02/2022
• Initial Date FDA Received: 08/26/2022
• Supplement Dates Manufacturer Received: 09/18/2022
• Supplement Dates FDA Received: 09/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/16/2021
• 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