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

Catalog Number 320122

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 03/29/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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.Investigation conclusion: unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failures as no samples or photos were returned.Root cause description: root cause cannot be determined at this time as the issues are unconfirmed as no samples or photos were returned.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that the bd ultra fine¿ pen needle was found bent after the injection, and very little insulin came from the bent needle, causing concern about whether the consumer had received a full dosage.Additionally, it was reported that the consumer did not test their glucose, not did they visually inspect the needle beforehand to ensure it was straight.The consumer also reported 3 occurrences of this event.The following information was provided by the initial reporter: "consumer reported about pen needle being bent after the injection.She sees little insulin coming out of the needle when its bent.She is concerned if she gets the full insulin.She did not test her glucose.She hasn't contacted the doctor, but will contact her after this call.She doesn't visually test to see if the needle is straight.She rotates her injection sight.She uses new needle each time of her injection.Occurrence: 3 times this week, incident date-unknown.".

Manufacturer Narrative

Investigation: customer returned (5) 32g x 4mm bd pen needles without tear drop labels attached (used).Consumer reported about pen needle being bent after the injection.She sees little insulin coming out of the needle when its bent.She is concerned if she gets the full insulin.All 5 returned pen needles were examined and the following was observed: 4 of the returned pen needles exhibited bent patient end cannula (see attached photos).1 of the returned pen needles exhibited a good patient end cannula.All 5 returned pen needles exhibited good non-patient end cannula.All 5 returned pen needles were tested for flow using a test pen injector: all 5 samples passed and no leakage was observed.No manufacturing defects were observed on the samples as the bent patient end cannula were possibly caused by user error.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.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (bent pe cannula) unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (leakage) the possible root cause for this issue (bent patient end cannula) is: user error.No evidence of manufacturing related issues were observed on the returned samples.Root cause cannot be determined at this time as the issue (leakage) is unconfirmed.

Event Description

It was reported that the bd ultra fine¿ pen needle was found bent after the injection, and very little insulin came from the bent needle, causing concern about whether the consumer had received a full dosage.Additionally, it was reported that the consumer did not test their glucose, not did they visually inspect the needle beforehand to ensure it was straight.The consumer also reported 3 occurrences of this event.The following information was provided by the initial reporter: "consumer reported about pen needle being bent after the injection.She sees little insulin coming out of the needle when its bent.She is concerned if she gets the full insulin.She did not test her glucose.She hasn't contacted the doctor, but will contact her after this call.She doesn't visually test to see if the needle is straight.She rotates her injection sight.She uses new needle each time of her injection.Occurrence: 3 times this week, incident date-unknown.".

• 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: 8515226
• MDR Text Key: 146385102
• Report Number: 9616656-2019-00357
• 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: consumer,other
• Type of Report: Initial,Followup
• Report Date: 04/29/2019

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: 320122
• Device Lot Number: 8247891
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/29/2019
• Initial Date FDA Received: 04/15/2019
• Supplement Dates Manufacturer Received: 03/29/2019
• Supplement Dates FDA Received: 04/29/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other