MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV; INSULIN SYRINGE WITH NEEDLE

Catalog Number	329461
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2018
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 barrel on a bd low-dose¿ u-100 insulin syringe with bd micro-fine¿ iv was found bowed/cracked prior to use.There was no report of exposure, serious injury, or medical intervention.
Additional Manufacturer Narrative
Investigation summary: customer returned a photo of a 1/2cc syringe.Customer states that there was an anomaly in the syringe.The attached photo was examined and exhibited a bowed/damaged barrel.A review of the device history record was completed for batch# 7121544.All inspections and challenges were performed per the applicable operations qc specifications.There was one notification 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.Possible root cause: molding processing issue (parts were blocked and associate didn't back off the plastic infeed, water problems, overpacking, etc.).Material handling (duration of components being stored in totes).

• Brand Name: BD LOW-DOSE¿ U-100 INSULIN SYRINGE WITH BD MICRO-FINE¿ IV
• Common Device Name: INSULIN SYRINGE WITH NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7571139
• Report Number: 1920898-2018-00407
• Device Sequence Number: 16214226
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2018

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: 06/30/2022
• Device Catalogue Number: 329461
• Device Lot Number: 7121544
• Initial Date Received by Manufacturer: 05/14/2018
• Supplement Date Received by Manufacturer: 05/14/2018
• Initial Report FDA Received Date: 06/05/2018
• Supplement Report FDA Received Date: 06/11/2018
• 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