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

Catalog Number 320109

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 12/06/2018

Event Type  malfunction  

Manufacturer Narrative

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 with the use of the bd ultra-fine¿ short insulin pen needle there was an issue with needle bending during injection and didn¿t get full dose of medication.

Manufacturer Narrative

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 per the applicable operations and met qc specifications.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle bending during use & difficult/unable to operate on lot # 8128625.Investigation conclusion: based on the samples / photo(s) received the investigation concluded: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.Rationale: based on the above, no additional investigation and no capa is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.

Event Description

It was reported with the use of the bd ultra-fine¿ short insulin pen needle there was an issue with needle bending during injection and didn't get full dose of medication.

• Brand Name: BD ULTRA-FINE¿ SHORT INSULIN PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8199815
• MDR Text Key: 131706949
• Report Number: 9616656-2018-00357
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903201099
• UDI-Public: 00382903201099
• Combination Product (y/n): N
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 12/31/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 05/31/2023
• Device Catalogue Number: 320109
• Device Lot Number: 8128625
• Initial Date Manufacturer Received: 12/07/2018
• Initial Date FDA Received: 12/27/2018
• Supplement Dates Manufacturer Received: 12/07/2018
• Supplement Dates FDA Received: 01/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other