MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE; INSULIN SYRINGE AND NEEDLE

Catalog Number 320468

Device Problems Loose or Intermittent Connection (1371); Detachment of Device or Device Component (2907)

Patient Problem No Patient Involvement (2645)

Event Date 06/21/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the needle of the bd ultra-fine ii¿ (short) self-contained insulin syringe was uncapped in the sealed package, and the shield was loose.Noticed before use.There was no report of exposure, injury, or medical intervention noted.

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: event attributed to: other.Device single use?: no.Device returned to manufacturer: no.

Event Description

It was reported that the needle of the bd ultra-fine ii¿ (short) self-contained insulin syringe was uncapped in the sealed package, and the shield was loose.Noticed before use.There was no report of exposure, injury, or medical intervention noted.

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.A review of the device history record was completed for batch#: 4055348.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification [128282] noted for raised needle assembly.There were two (2) notifications [128275, 128281] noted that did not pertain to the complaint.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 the needle of the bd ultra-fine ii¿ (short) self-contained insulin syringe was uncapped in the sealed package, and the shield was loose.Noticed before use.There was no report of exposure, injury, or medical intervention noted.

• Brand Name: BD ULTRA-FINE II¿ (SHORT) SELF-CONTAINED INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7692849
• MDR Text Key: 114547783
• Report Number: 1920898-2018-00503
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• 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: 07/16/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2019
• Device Catalogue Number: 320468
• Device Lot Number: 4055348
• Date Manufacturer Received: 06/21/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other