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	06/18/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.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 bd ultra-fine¿ insulin syringe had "insulin leak around the needle hub during injection".No serious injury or medical intervention reported.
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: sex: male.Event attributed to: other.Device single use?: no.Device returned to manufacture: yes.
Event or Problem Description
It was reported that bd ultra-fine¿ insulin syringe had "insulin leak around the needle hub during injection".No serious injury or medical intervention reported.
Additional Manufacturer Narrative
Investigation summary: customer returned to franklin lakes (1) 1cc, 8mm, 31g syringe in an open poly bag from lot # 7241532.Customer states that insulin leaks around the needle hub.The returned syringe was tested and was not able to draw properly.The sample was then examined under the microscope and exhibited adhesive runoff onto the barrel.This could cause leakage as there is insufficient adhesive in the hub.Sample were forwarded to manufacturing (holdrege) on 20jul2018 for further review.On 26jul2018, holdrege received one (1) 1ml, 8mm, 31g syringe in an opened polybag from batch # 7241532.All samples are decontaminated per hstr-17 prior to being evaluated.Upon evaluation by qe ah, similar findings to those documented during initial investigation performed at bd franklin lakes were noted.The returned sample was visualized under ultraviolet lighting and confirmed the presence of adhesive along the exterior side and barrel tip side well.Trace adhesive was noted within the barrel tip itself.Probable root cause is a misalignment of the adhesive nozzle during application on the pils (point inspect lube shield) equipment.When this occurs, there is a greatly increased chance of finding adhesive applied to unintended portions of the barrel tip and barrel tip side well, as is noted within the returned sample.Capa 226773 was initiated by the holdrege plant to address 1ml customer complaints and their associated root cause(s).Batch# 7241532 was manufactured prior to implementation of any corrective/preventive actions associated with this capa.A review of the device history record was completed for batch# 7241532.All inspections were performed per the applicable operations qc specifications.There were three (3) notifications [200712892, 200712495, 200712933] noted that did not pertain to the complaint.Severity: s_1__; occurrence: a complaint history check was performed and this is the 4th related complaint for leakage on lot # 7241532.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).Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that bd ultra-fine¿ insulin syringe had "insulin leak around the needle hub during injection".No serious injury or medical intervention reported.

• Brand Name: BD ULTRA-FINE¿ INSULIN SYRINGE
• Common Device Name: SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7679514
• Report Number: 1920898-2018-00500
• Device Sequence Number: 1316309
• Product Code: FMF
• UDI-Device Identifier: 00382903294169
• UDI-Public: 00382903294169
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/18/2018
• Supplement Date Received by Manufacturer: 06/18/2018; 06/18/2018
• Initial Report FDA Received Date: 07/11/2018
• Supplement Report FDA Received Date: 08/09/2018; 09/11/2018
• 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