MAUDE Adverse Event Report: BECTON DICKINSON AND CO. PEN NDL 32G 4MM HP 100 BOX 1200 US; PEN NEEDLE

Model Number 320550

Device Problem Failure to Deliver (2338)

Patient Problems Irritation (1941); Skin Inflammation/ Irritation (4545)

Event Date 10/27/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer 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.(b)(4).

Event Description

It was reported that pen ndl 32g 4mm hp 100 box 1200 us was clogged during injection.The following information was provided by the initial reporter: material no.320550, batch no.9338807.It was reported that needles clog during injection and bend causing marks on skin.

Manufacturer Narrative

H.6.Investigation: 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 as per the applicable operations and met qc specifications.H3 other text : see h.10.

Event Description

It was reported that pen ndl 32g 4mm hp 100 box 1200 us was clogged during injection.The following information was provided by the initial reporter: material no.320550 batch no.9338807.It was reported that needles clog during injection and bend causing marks on skin.

• Brand Name: PEN NDL 32G 4MM HP 100 BOX 1200 US
• Type of Device: PEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 10872753
• MDR Text Key: 218273372
• Report Number: 9616656-2020-01167
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• PMA/PMN Number: K182320
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 03/31/2021

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: Lay User/Patient
• Device Model Number: 320550
• Device Catalogue Number: 320550
• Device Lot Number: 9338807
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2020
• Initial Date Manufacturer Received: 10/27/2020
• Initial Date FDA Received: 11/19/2020
• Supplement Dates Manufacturer Received: 03/31/2021
• Supplement Dates FDA Received: 04/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1