MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD PEN NDL 32G 4MM HP; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320562

Device Problems Failure to Deliver (2338); Material Deformation (2976)

Patient Problem Underdose (2542)

Event Date 09/06/2019

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 and/or device history review, a supplemental report will be filed.

Event Description

It was reported that during use of the bd pen ndl 32g 4mm hp the needle bends when injecting insulin.The user does not receive his full dose of insulin.The following information was provided by the initial reporter, translated from french to english: the new bd needles 4mm, the needle bends when injecting insulin.He does not receive his full dose of insulin.

Manufacturer Narrative

H.6.Investigation: seven sealed 32g x 4mm pen needle samples were returned from lot no.8205960 cat.No.320562.Visual examination was carried out on all seven samples and no issues were observed.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.No issues were observed with the returned samples therefore no root cause can be identified.

Event Description

It was reported that during use of the bd pen ndl 32g 4mm hp the needle bends when injecting insulin.The user does not receive his full dose of insulin.The following information was provided by the initial reporter, translated from french to english: the new bd needles 4mm, the needle bends when injecting insulin.He does not receive his full dose of insulin.

• Brand Name: BD PEN NDL 32G 4MM HP
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• MDR Report Key: 9112558
• MDR Text Key: 189904298
• Report Number: 9616656-2019-00902
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 10/18/2019

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: 08/31/2023
• Device Catalogue Number: 320562
• Device Lot Number: 8205960
• Initial Date Manufacturer Received: 09/06/2019
• Initial Date FDA Received: 09/24/2019
• Supplement Dates Manufacturer Received: 09/06/2019
• Supplement Dates FDA Received: 10/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other