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

Catalog Number	329416
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/25/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.Medical device expiration date: n/a.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 with the use of the bd ultra-fine insulin syringe there was an issue with needle breaking and hole in syringe.There was no report of injury or further 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 manufacturer: yes.
Event or Problem Description
It was reported with the use of the bd ultra-fine insulin syringe there was an issue with needle breaking and hole in syringe.There was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Investigation summary: customer returned (1) 1cc, 8mm, 31g syringe in an open poly bag from lot # 7241532.Customer states that the needle broke off in the vial and there is a hole in the hub and barrel.The returned syringe was examined under the microscope and exhibited a detached cannula.The barrel exhibited adhesive runoff onto the he barrel tip and little adhesive was observed inside the hub.No holes in the barrel or hub were observed.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.Based on the samples / photo(s) received the investigation concluded: -confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (adhesive runoff onto barrel) -unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (holes in barrel and hub) investigation conclusion: probable root cause determined to be misalignment during application of adhesive on the needle lines.When this occurs, adhesive runover onto the hub or possible the cannula may occur.Additionally, adhesive may be inaccurately applied to the rubberized pull wheel on the line, which can additionally transfer adhesive to the cannula during routine use.Capa 226773 has been opened to address this issue for 1ml syringes.
Event or Problem Description
It was reported with the use of the bd ultra-fine insulin syringe there was an issue with needle breaking and hole in syringe.There was no report of injury or further 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: 7695836
• Report Number: 1920898-2018-00509
• Device Sequence Number: 11095182
• Product Code: FMF
• UDI-Device Identifier: 00382903294169
• UDI-Public: 00382903294169
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 08/14/2018

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: 06/25/2018
• Supplement Date Received by Manufacturer: 06/25/2018; 06/25/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 08/07/2018; 09/19/2018
• 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