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

Catalog Number 329416

Device Problems Loose or Intermittent Connection (1371); Material Separation (1562); Component Missing (2306)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/14/2018

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: n/a.Initial reporter: address unavailable.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 a bd ultra-fine insulin syringe "was missing the needle.Another syringe had the needle inserted into the plastic end off- center not connected to the chamber.It was also reported that the syringe was loose and when pulled out of the vial the needle had separated from the syringe".No report of serious injury or medical intervention.

Event Description

It was reported that a bd ultra-fine insulin syringe "was missing the needle.Another syringe had the needle inserted into the plastic end off- center not connected to the chamber.It was also reported that the syringe was loose and when pulled out of the vial the needle had separated from the syringe." no report of serious 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: event attributed to: other.Device single use?: no.Device returned to manufacture: no.

Manufacturer Narrative

Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 7241532.All inspections were performed per the applicable operations qc specifications.There were two (2) notifications [200712856, 200712892] noted for insufficient adhesive.There were five (5) notifications [200712495, 200712933, 200712764, 200712494, 200712877] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 1st related complaint for needle missing, incorrect placement of needle and needle loose and the 2nd related complaint for needle separates in vial on lot # 7241532.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.Based on the above, no additional investigation and no capa is required at this time.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.

Event Description

It was reported that a bd ultra-fine insulin syringe "was missing the needle.Another syringe had the needle inserted into the plastic end off- center not connected to the chamber.It was also reported that the syringe was loose and when pulled out of the vial the needle had separated from the syringe." no report of serious injury or medical intervention.

• Brand Name: BD ULTRA-FINE INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7656404
• MDR Text Key: 113189606
• Report Number: 1920898-2018-00479
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903294169
• UDI-Public: 00382903294169
• 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: 09/04/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 329416
• Device Lot Number: 7241532
• Date Manufacturer Received: 06/14/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other