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

Catalog Number	329416
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/14/2018
Type of Reportable Event	Malfunction
Additional 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 or Problem 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 or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7656404
• Report Number: 1920898-2018-00479
• Device Sequence Number: 16525055
• Product Code: FMF
• UDI-Device Identifier: 00382903294169
• UDI-Public: 00382903294169
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Patient
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/04/2018

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
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 329416
• Device Lot Number: 7241532
• Initial Date Received by Manufacturer: 06/14/2018
• Supplement Date Received by Manufacturer: 06/14/2018; 06/14/2018
• Initial Report FDA Received Date: 07/02/2018
• Supplement Report FDA Received Date: 07/31/2018; 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other