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

Catalog Number 328278

Device Problem Failure to Advance (2524)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/11/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: unknown.Device manufacture date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.

Event Description

It was reported that when drawing up medication with a bd ultra-fine¿ needle insulin syringe, the medication the medication goes back into the vial.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

Correction: 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: sex: male.Event attributed to: other.Device single use?: no.Device returned to manufacture: yes.This supplemental mdr also corrects the event description: it was reported that when drawing up medication with a bd ultra-fine¿ needle insulin syringe, the medication goes back into the vial.There was no report of exposure, injury or medical intervention.

Event Description

It was reported that when drawing up medication with a bd ultra-fine¿ needle insulin syringe, the medication goes back into the vial.There was no report of exposure, injury or medical intervention.

Manufacturer Narrative

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.Unable to complete dhr check as lot number is unknown.Based on the samples / photo(s) 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.Investigation conclusion: root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.

Event Description

It was reported that when drawing up medication with a bd ultra-fine¿ needle insulin syringe, the medication the medication goes back into the vial.There was no report of exposure, injury or medical intervention.

• Brand Name: BD ULTRA-FINE¿ NEEDLE INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7658678
• MDR Text Key: 113289657
• Report Number: 1920898-2018-00468
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903282784
• UDI-Public: 00382903282784
• 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: 08/14/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/03/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328278
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 06/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other