MAUDE Adverse Event Report: BECTON DICKINSON AND CO. BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number 320109

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 12/16/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: level a investigation - complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for leakage & difficult/unable to operate on lot # 9121986.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 conformance's were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: 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.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: root cause cannot be determined at this time as the issue is 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 has been reported that one bd ultra-fine¿ short pen needles 8mm (5/16¿) 31g has been found experiencing under dosage during use.The following has been provided by the initial reporter: it was reported that after injection needle left blob of insulin on skin.She is not sure if she got the whole injection.Verbatim: issue: consumer reported after the injection needle left big blob of insulin on her skin.She is not sure if the insulin went in.She has used the 8mm needle before, this needle was dropped off by a nurse at her assistant living facility.Nurse brought the 8mm pen needle, but it looks different than the one she used.She provided item# as 320109 from the previous box.The lot# provided from the tear off label she had an issue with.Sample discarded.Incident date-(b)(6) 2019, occurence-1, item# 320109, lot# 9121986; expiration date- 2024-05-31.She uses the new needle for her injection.No one told her about visually testing the needle.

• Brand Name: BD ULTRA-FINE¿ SHORT PEN NEEDLES 8MM (5/16¿) 31G
• 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: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9536512
• MDR Text Key: 190782800
• Report Number: 9616656-2019-01290
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403801518
• UDI-Public: 10885403801518
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162516
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 320109
• Device Lot Number: 9121986
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/16/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/01/2019
• 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
• Patient Outcome(s): Other