MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320122

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 06/24/2019

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

Material no.: 320122 , batch no.: 8270626.It was reported that during use of the bd ultra-fine¿ nano¿ pen needles 4mm as the consumer is administering her insulin shot, half way through her injection nothing comes out of the needle.The dos is 25 units and only 19 units dispensed.There were ten occurrences.Consumer reported during the injection after half way through, nothing comes out of the needle.She takes 25 units of insulin.On (b)(6) 2019, only 19 units of insulin dispensed and only the 3rd needle worked.She only does the priming for the new insulin pen only.Always rotates the injection site and uses new pen needles for each time of her injection.

Event Description

Material no.: 320122, batch no.: 8270626.It was reported that during use of the bd ultra-fine¿ nano¿ pen needles 4mm as the consumer is administering her insulin shot, half way through her injection nothing comes out of the needle.The dos is 25 units and only 19 units dispensed.There were ten occurrences consumer reported during the injection after half way through, nothing comes out of the needle.She takes 25 units of insulin.On (b)(6) 2019, only 19 units of insulin dispensed and only the 3rd needle worked.She only does the priming for the new insulin pen only.Always rotates the injection site and uses new pen needles for each time of her injection.

Manufacturer Narrative

H.6.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.As no samples and/or photo(s) were received the investigation concluded: -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure as no samples or photos were returned.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: BD ULTRA-FINE¿ NANO¿ PEN NEEDLES 4MM
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• MDR Report Key: 8782983
• MDR Text Key: 160232754
• Report Number: 9616657-2019-00260
• 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: 07/16/2019

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: 10/31/2023
• Device Catalogue Number: 320122
• Device Lot Number: 8270626
• Initial Date Manufacturer Received: 06/24/2019
• Initial Date FDA Received: 07/11/2019
• Supplement Dates Manufacturer Received: 06/24/2019
• Supplement Dates FDA Received: 07/18/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other