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

Catalog Number	928852
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/06/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
Event or Problem Description
It was reported that the plunger rod of a bd¿ insulin syringe with needle was ¿hard to move¿.There was no report of exposure, injury or medical intervention.
Additional Manufacturer Narrative
Investigation summary: customer returned (11) loose 3/10cc, 12.7mm syringes.Customer states that the plunger is difficult to move.All returned syringes were tested and all were able to draw and expel properly without any observed defects.A review of the device history record was completed for batch# 7254995.All inspections and challenges were performed per the applicable operations qc specifications.There were three (3) notifications [(b)(4)] 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 plunger rod difficult to move on lot # 7254995 based on the samples / photo(s) received the investigation concluded: - unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure.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.
Event or Problem Description
It was reported that the plunger rod of a bd¿ insulin syringe with needle was ¿hard to move¿.There was no report of exposure, injury or medical intervention.

• Brand Name: BD¿ INSULIN SYRINGE WITH NEEDLE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7648230
• Report Number: 1920898-2018-00463
• Device Sequence Number: 19243840
• Product Code: FMF
• UDI-Device Identifier: 00311917014920
• UDI-Public: 00311917014920
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K941657
• 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): 07/12/2018

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: Other
• Device Expiration Date: 09/30/2022
• Device Catalogue Number: 928852
• Device Lot Number: 7254995
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/27/2018
• Initial Date Received by Manufacturer: 06/08/2018
• Supplement Date Received by Manufacturer: 06/08/2018
• Initial Report FDA Received Date: 06/28/2018
• Supplement Report FDA Received Date: 07/17/2018
• 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