MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Model Number 328418

Device Problems Break (1069); Defective Device (2588)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 01/22/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 needle missing, bending during use and breaks off during use on lot # 9091562.Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.If samples are received in the future the complaint will be reopened for further investigation.A review of the device history record was completed for batch# 9091562.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200815571] noted that did not pertain to the complaint.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 was reported that bd insulin syringe with the bd ultra-fine¿ needle are damaged.This was discovered during use.The following information was provided by the initial reporter: material no: 328418 batch no: 9091562.It was reported that one syringe was missing the needle, hub was still attached to the syringe but needle was missing.Also stated that the needles bend when injecting and one needle broke off into the injection site during injection.Consumer was able to remove the needle with a tweezer.Verbatim: hello.I have been a diabetic for about 25 years and i use bd syringes for my insulin.Typically, i never have any issues with the syringes, however i wanted to make you aware of something which has recently occurred.Some syringes i've recently received from my pharmacy appear to be defective.I receive a box of 100 syringes and in a couple of the packages, the syringes are either missing the needles or, and this is worse, the needles will bend or break when i attempt an injection.This is definitely not a regular occurrence and it certainly won't prevent me from using your product! i just wanted to make someone aware of what happened.Thank you very much and i hope everyone has a wonderful day! per update in snow (b)(6) 2020.Consumer called back and provided additional information.Stated that one syringe was missing the needle, hub was still attached to the syringe but needle was missing.Also stated that the needles bend when injecting and one needle broke off into the injection site during injection.Consumer was able to remove the needle with a tweezer.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9655659
• MDR Text Key: 194929813
• Report Number: 1920898-2020-00064
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• 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: 01/23/2020

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: 03/31/2024
• Device Model Number: 328418
• Device Catalogue Number: 328418
• Device Lot Number: 9091562
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/22/2020
• Initial Date FDA Received: 01/31/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2019
• 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