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	05/04/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.No lot # provided, medical device expiration date: unknown, device manufacture date: unknown.A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that the needle on a bd ultra-fine¿ insulin syringe broke off into the vial when drawing the medication.There was no report of injury or medical interventions.
Additional Manufacturer Narrative
Investigation summary: investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Dhr could not be performed as the lot number was not provided.Severity: s_1__; occurrence: a complaint history check could not be performed for the defect/condition reported since the lot number was not provided.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.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.If samples are received in the future the complaint will be reopened for further investigation.

• 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: 7534195
• Report Number: 1920898-2018-00348
• Device Sequence Number: 167607
• 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: Patient
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2018

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: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 05/04/2018
• Supplement Date Received by Manufacturer: 05/04/2018
• Initial Report FDA Received Date: 05/22/2018
• Supplement Report FDA Received Date: 05/29/2018
• 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