MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS; PISTON SYRINGE

Catalog Number 328468

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 11/21/2019

Event Type  Injury  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: level b investigation.Complaint evaluation / complaint history check for the event(s) that occurred.Severity: s_3__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle breaks off during use and needle blunt on lot # 9084991.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 review of the device history record was completed for batch# 9084991.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained 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 has been reported that one bd¿ syringe 0.5ml 31ga 8mm ufii 10bag 500cs has been found with the cannula breaking before use.The following has been provided by the initial reporter: it was reported that 4 weeks ago, the customer was attempting to draw medication from vial and needle "snapped off" instead of puncturing vial.The piece that "snapped off" landed on the floor.Consumer stated, she stepped onto needle when she was searching for it on floor and got lodged into her left foot.Customer stated that out of the last two boxes she purchased, she got at least 2 or 3 syringes per box she could not use because needle did not penetrate vial.Verbatim: consumer called in to report, she is scheduled for surgery tomorrow due to needle break in her left foot stated, 4 weeks ago, she was attempting to draw medication from vial and needle "snapped off" instead of puncturing vial the piece that "snapped off" landed on the floor consumer stated, she stepped onto needle when she was searching for it on floor and got lodged into her left foot.Stated, she went to medical center and had x-ray done.((b)(6) 2019) stated, x-ray showed needle.Stated, out of the last two boxes she purchased, she got at least 2 or 3 syringes per box she could not use because needle did not penetrate vial.Lot: 9084991, item: 328468.Expiration date: 2024-03-31.

• Brand Name: BD SYRINGE 0.5ML 31GA 8MM UFII 10BAG 500CS
• 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: 9429929
• MDR Text Key: 185573365
• Report Number: 1920898-2019-01387
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• 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: 11/26/2019

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: 03/31/2024
• Device Catalogue Number: 328468
• Device Lot Number: 9084991
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/21/2019
• Initial Date FDA Received: 12/06/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/25/2019
• 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): Required Intervention