MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA FINE¿ PEN NEEDLE

Catalog Number 320119

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 07/26/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

Material no.320119, batch no.9022887.It was reported that during use of the bd ultra fine¿ pen needle the needle clogged during injection.Only eight units out of the ten were delivered.The following information was provided by the initial reporter: consumer reported during his injection this morning, insulin flow stopped before he could complete his 10 units.He only received 8 units of insulin.He did not use a second pen needle to get additional 2 units.Does prime before use.

Manufacturer Narrative

H.6.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.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.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.As no samples and/or photo(s) were 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.Based on the above, no additional investigation and no capa is required at this time.H3 other text : see section h.10.

Event Description

Material no.320119.Batch no.9022887.It was reported that during use of the bd ultra fine¿ pen needle the needle clogged during injection.Only eight units out of the ten were delivered.The following information was provided by the initial reporter: consumer reported during his injection this morning, insulin flow stopped before he could complete his 10 units.He only received 8 units of insulin.He did not use a second pen needle to get additional 2 units.Does prime before use.

• Brand Name: BD ULTRA FINE¿ PEN NEEDLE
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 8890869
• MDR Text Key: 154450823
• Report Number: 9616656-2019-00742
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403811012
• UDI-Public: 10885403811012
• 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: 09/04/2019

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: 01/31/2024
• Device Catalogue Number: 320119
• Device Lot Number: 9022887
• Initial Date Manufacturer Received: 07/26/2019
• Initial Date FDA Received: 08/13/2019
• Supplement Dates Manufacturer Received: 07/26/2019
• Supplement Dates FDA Received: 09/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other