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

Catalog Number 320144

Device Problem Failure to Deliver (2338)

Patient Problems Hematoma (1884); Irritation (1941); Skin Inflammation/ Irritation (4545)

Event Date 10/15/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8197889, medical device expiration date: 2023-07-31, device manufacture date: 2018-07-16, medical device lot #: 0091873, medical device expiration date: 2025-03-31, device manufacture date: 2020-03-31, medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that lantus insulin would not flow through the bd ultra-fine¿ pen needles during the injections and flow check.Lots 8197889, 0091873.And an unspecified lot each had 1 occurrence of these events.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "consumer wife reported finding lantus will not go thru the needles during flow check and injections.Claims leaving bruises and bumps on husbands tummy.Denied reuse of pen needles.Claims does the flow check sees clogs during flow check and injection.Informed of non patient end placement caller did not like this process".

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 lantus insulin would not flow through the bd ultra-fine¿ pen needles during the injections and flow check.Lots 8197889, 0091873.And an unspecified lot each had 1 occurrence of these events.This complaint was created to capture the 3rd of 3 related incidents.The following information was provided by the initial reporter: "consumer wife reported finding lantus will not go thru the needles during flow check and injections.Claims leaving bruises and bumps on husbands tummy.Denied reuse of pen needles.Claims does the flow check sees clogs during flow check and injection.Informed of non patient end placement caller did not like this process".

• Brand Name: BD ULTRA-FINE PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 10786094
• MDR Text Key: 216690521
• Report Number: 9616656-2020-01099
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/15/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320144
• Device Lot Number: SEE SECTION H.10.
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/15/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1