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

Catalog Number 320122

Device Problem Failure to Deliver (2338)

Patient Problem Underdose (2542)

Event Date 05/08/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: level a investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_2__; occurrence: a complaint history check was performed and this is the 1st related complaint for clog & difficult/unable to operate on lot # 8311933.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.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 was reported that the pen stops working during priming and they were unable to deliver medication with a bd ultra fine¿ pen needles.The following information was provided by the initial reporter: material no.320122, batch no.8311933.It was reported that pen needle does not work during priming.Insulin stops halfway through injection and it's hard to push the plunger down after that.Verbatim: consumer reported some of the pen needle doesn't work during the priming and some of them doesn't dispense the complete insulin in to this body.He uses 20 units of the insulin and its stops after the 10 units injection, its hard for him to push the plunger after that.He thinks the needle is not completely opening and it shuts somewhere in the middle of the injection.Partially blocked.Sample - discarded; occurrence-unknown; incident date-(b)(6) 2019; item# 320122; lot# 8311933; expiration date-2023-11-30.He always uses new pen needle for his injection.

• Brand Name: BD ULTRA FINE¿ PEN NEEDLES
• 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: 8633242
• MDR Text Key: 146682705
• Report Number: 9616656-2019-00470
• Device Sequence Number: 1
• Product Code: FMI
• UDI-Device Identifier: 10885403928659
• UDI-Public: 10885403928659
• 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: 05/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 11/30/2023
• Device Catalogue Number: 320122
• Device Lot Number: 8311933
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/07/2018
• 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