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

Catalog Number 320749

Device Problem Failure to Deliver (2338)

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

Event Date 12/08/2022

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¿ micro pen needles are too short and not the 6mm.The following information was provided by the initial reporter: stated, the ones in the box are too short and not 6mm.Stated pen needles in the box are 3mm because she measured it.

Event Description

It was reported that the bd ultra-fine¿ micro pen needles are too short and not the 6mm.The following information was provided by the initial reporter: stated, the ones in the box are too short and not 6mm.Stated pen needles in the box are 3mm because she measured it.

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 a total of 70 unused 6mm, 32 gauge pen needles from lot 2054713.It was reported by the consumer that pen needles are bruising her skin, also needles are too short.The returned samples(30) were measured for cannula length using comparator and all the needles cannula length was measured within the specified acceptance limits.Hence, the alleged issue could not be confirmed based on the samples return.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 not able to confirm the customer indicated failure.Root cause cannot be determined at this time as the issue is unconfirmed.

• Brand Name: BD ULTRA-FINE¿ MICRO 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: 16056786
• MDR Text Key: 308540987
• Report Number: 9616656-2022-01414
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/16/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320749
• Device Lot Number: 2054713
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/16/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/23/2022
• 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