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

Catalog Number 328418

Device Problem Contamination (1120)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/16/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Investigation summary: customer returned a photo of a cannula.Customer states that he noticed what looked like an actual piece of tissue adhering near the tip of the needle itself.The attached photo was examined and exhibited a piece of material on the cannula shaft.However, it is difficult to determine the identity of the observed fm on the cannula without the actual sample.A review of the device history record was completed for batch# 7353795.All inspections were performed per the applicable operations qc specifications.There were five (5) notifications [(b)(4)] noted that did not pertain to the complaint.Investigation conclusion based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure.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 identity of the fm observed on the cannula cannot be determined without the actual sample.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that before use a tissue like foreign matter was on the needle tip of the bd insulin syringe with bd ultra-fine¿ needle.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Awareness date corrected from: 16-jul-2018 corrected to: 15-jul-2018.Date received by manufacturer: 7/15/2018.

Event Description

It was reported that before use a tissue like foreign matter was on the needle tip of the bd insulin syringe with bd ultra-fine¿ needle.There was no report of exposure, injury, or medical intervention noted.

Event Description

It was reported that before use a tissue like foreign matter was on the needle tip of the bd insulin syringe with bd ultra-fine¿ needle.There was no report of exposure, injury, or medical intervention noted.

Manufacturer Narrative

Due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: b.2.Event attributed to: other, d.8.Device single use?: no, h.3.Device returned to manufacture: no.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE¿ NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7752968
• MDR Text Key: 116250086
• Report Number: 1920898-2018-00576
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908418034
• UDI-Public: 00382908418034
• Combination Product (y/n): N
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup,Followup
• Report Date: 09/28/2018

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: 12/31/2022
• Device Catalogue Number: 328418
• Device Lot Number: 7353795
• Initial Date Manufacturer Received: 07/16/2018
• Initial Date FDA Received: 08/06/2018
• Supplement Dates Manufacturer Received: 07/16/2018; 07/15/2018
• Supplement Dates FDA Received: 09/19/2018; 09/28/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other