MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD NANO¿ 2ND GEN PEN NEEDLE; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320550

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

Patient Problem Easy Bruising (4558)

Event Date 07/24/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.E.1.The customer's address is unknown.(b)(6), usa has been used as a placeholder based on the reported phone area code.H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd nano¿ 2nd gen pen needle was difficult to operate and leaked out insulin during the injection.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "consumer wife reported via voice message - husbands pen needles bend when injecting.Insulin runs down belly/site not getting his insulin consumer wife reported via voice message she has stuck herself several times from bent needles.Caller noted her finger stick site is bruised going under her nail.No medical attention needed.Caller noticed her husband has bruises at injection site.No medical attention needed.".

Manufacturer Narrative

Investigation summary 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.

Event Description

It was reported that the bd nano¿ 2nd gen pen needle was difficult to operate and leaked out insulin during the injection.This complaint was created to capture the 1st of 2 related incidents.The following information was provided by the initial reporter: "consumer wife reported via voice message - husbands pen needles bend when injecting.Insulin runs down belly/site not getting his insulin consumer wife reported via voice message she has stuck herself several times from bent needles.Caller noted her finger stick site is bruised going under her nail.No medical attention needed.Caller noticed her husband has bruises at injection site.No medical attention needed.".

• Brand Name: BD NANO¿ 2ND GEN PEN NEEDLE
• Type of Device: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer (Section G): BECTON DICKINSON AND CO.; pottery road; dun laoghaire co
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17511482
• MDR Text Key: 321048783
• Report Number: 9616656-2023-00877
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 00382903205509
• UDI-Public: 00382903205509
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K212015
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320550
• Device Lot Number: 2320083
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/18/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/16/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1