MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD¿ INSULIN SYRINGE WITH NEEDLE; INSULIN SYRINGE AND NEEDLE

Catalog Number	928852
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	01/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 the scale markings on a bd¿ insulin syringe with needle were incorrect (described as ¿some are up at the top and others are a half inch below the top¿).This was observed before use and there was no report of injury or medical interventions.
Additional Manufacturer Narrative
Investigation results: severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint reported for the defect/condition on lot number 6347588.As per manufacturing, a review of the device history record was completed for batch # 6347588 all inspections were performed per the applicable operations qc specifications.There was one (1) notification [200676262] noted for print out of registration.Investigation summary: customer returned (2) 3/10cc, 12.7mm 29g walgreens syringes in an open poly bag from lot # 6347588.Customer states that the syringe scale markings seem to be off.Both returned syringes were tested using the plug gauge and all scale markings fall within specifications.Conclusion: bd was not able to duplicate or confirm the customer¿s indicated failure.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.Based on the above, no additional investigation and no capa is required at this time.

• Brand Name: BD¿ INSULIN SYRINGE WITH NEEDLE
• Common Device Name: INSULIN SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7266920
• Report Number: 1920898-2018-00041
• Device Sequence Number: 1028420
• Product Code: FMF
• UDI-Device Identifier: 00311917014920
• UDI-Public: 00311917014920
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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): 02/22/2018

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 Expiration Date: 12/31/2021
• Device Catalogue Number: 928852
• Device Lot Number: 6347588
• Initial Date Received by Manufacturer: 01/22/2018
• Supplement Date Received by Manufacturer: 01/22/2018
• Initial Report FDA Received Date: 02/13/2018
• Supplement Report FDA Received Date: 02/22/2018
• 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