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

Model Number 2865

Device Problems Leak/Splash (1354); Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 12/11/2019

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that bd ultra fine¿ pen needles leaked during use.This occurred on 4 occasions.The following information was provided by the initial reporter: material no.320122 batch no.9113867.It was reported that during injection insulin ran down leg and when he pulled needle out of injection site it was bent.Verbatim: from phone call on 2019-12-13 15:49:21: consumer returned call and stated that when he was doing his injection, he noticed insulin running down his leg.When he removed the needle he saw that it was bent over and realized that the insulin did not go into his skin.Consumer did not mention any of the needles breaking off.No additional information was provided.Consumer received replacement from the pharmacy.From phone call on 2019-12-13 11:54:52: follow up#2, spoke to the pharmacist, she stated she has not heard from a consumer, she will call again.Confirmed case number.Explained the pharmacist, i have processed the request to replaced the box.(bea).From phone call on 2019-12-12 10:38:56: followed up, left message with another pharmacist for updates.(bea) returned call, spoke to the pharmacist.Pharmacist stated when consumer giving injection insulin ran down the leg, when he pulled it out needle bent.He is not new to the insulin.Consumer uses new needle for his injection.She stated consumer reported it has happened with total of 4 of 5 pen needle.She also stated needle broke, she does not know if the consumer stated needle was detached or it was just bent.Provided case #, she will reach out to the consumer to contact us for updates.She has a unused pen needle from the box consumer dropped.Advised to send us 3 unused samples.Pharmacy has replaced 5mm 31g needle to see if he would like the longer needles.Explained to re check with the doctor for size, offered to send the replacement to the pharmacy (bea).Email received.Hello, we received a voicemail, stated that the customer returned a box bd nano 4mm pen needle because they are malfunctioning.

Manufacturer Narrative

H.6.Investigation: customer returned (95) sealed 4mm, 32g pen needles with the shelf carton from lot # 8263490.Customer states that insulin ran down the leg and the needle was bent.Thirty out of 95 returned pen needles were tested for point geometry, lube, and cannula od.All observations fall within specifications.All 30 samples were also tested and all were able to expel properly without any observed defects.Level a 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.Root cause cannot be determined at this time as the issue is unconfirmed.

Event Description

It was reported that bd ultra fine¿ pen needles leaked during use.This occurred on 4 occasions.The following information was provided by the initial reporter: material no.320122 batch no.9113867 it was reported that during injection insulin ran down leg and when he pulled needle out of injection site it was bent.Verbatim: from phone call on (b)(6) 15:49:21: consumer returned call and stated that when he was doing his injection, he noticed insulin running down his leg.When he removed the needle he saw that it was bent over and realized that the insulin did not go into his skin.Consumer did not mention any of the needles breaking off.No additional information was provided.Consumer received replacement from the pharmacy.From phone call on (b)(6) 11:54:52: follow up#2, spoke to the pharmacist, she stated she has not heard from a consumer, she will call again.Confirmed case number.Explained the pharmacist, i have processed the request to replaced the box.((b)(6)) from phone call on (b)(6) 2019 10:38:56: followed up, left message with another pharmacist for updates.((b)(6)) returned call, spoke to the pharmacist.Pharmacist stated when consumer giving injection insulin ran down the leg, when he pulled it out needle bent.He is not new to the insulin.Consumer uses new needle for his injection.She stated consumer reported it has happened with total of 4 of 5 pen needle.She also stated needle broke, she does not know if the consumer stated needle was detached or it was just bent.Provided case #, she will reach out to the consumer to contact us for updates.She has a unused pen needle from the box consumer dropped.Advised to send us 3 unused samples.Pharmacy has replaced 5mm 31g needle to see if he would like the longer needles.Explained to re check with the doctor for size, offered to send the replacement to the pharmacy ((b)(6)) email received.Hello, we received a voicemail, stated that the customer returned a box bd nano 4mm pen needle because they are malfunctioning.

• Brand Name: BD ULTRA FINE¿ PEN NEEDLES
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 9526486
• MDR Text Key: 191021658
• Report Number: 9616657-2019-00388
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: 10885403928659
• Combination Product (y/n): N
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 02/04/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/27/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 2865
• Device Catalogue Number: 320122
• Device Lot Number: 9113867
• Date Manufacturer Received: 12/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other