MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1/2 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 30G X 5/16 NEEDLE

Catalog Number	305934
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	05/16/2018
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 a 1/2 ml bd safetyglide¿ insulin syringe with 30g x 5/16 needle had a "bead" inside the syringe.
Event or Problem Description
It was reported that a 1/2 ml bd safetyglide¿ insulin syringe with 30g x 5/16 needle had a "bead" inside the syringe.
Additional Manufacturer Narrative
Investigation summary: customer returned photos of a bd safetyglide insulin syringe.Customer states that there is a bead inside the syringe.The photos were examined and exhibited what appeared to be a piece of plastic inside the barrel.A review of the device history record was completed for batch# 7044686.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained 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.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.Possible root cause: the grinder at the mold press can discharge barrel runner pieces which are kicked out of the grinder and the air transfer system for the parts pulls the regrind pieces into the tote with the molded barrels.Static charge can cause the runner pieces to adhere to the tote or molded components.Totes of molded components are transferred to the assembly operations, which then are emptied into the vibratory bin.This can dislodge the regrind piece, which can potentially find its way into the barrel fluid path.

• Brand Name: 1/2 ML BD SAFETYGLIDE¿ INSULIN SYRINGE WITH 30G X 5/16 NEEDLE
• Common Device Name: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 8181216
• Report Number: 1920898-2018-00972
• Device Sequence Number: 13928851
• Product Code: FMF
• UDI-Device Identifier: 00382903059348
• UDI-Public: 382903059348
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K992734
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2019

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: 03/31/2022
• Device Catalogue Number: 305934
• Device Lot Number: 7044686
• Initial Date Received by Manufacturer: 12/11/2018
• Supplement Date Received by Manufacturer: 12/11/2018
• Initial Report FDA Received Date: 12/19/2018
• Supplement Report FDA Received Date: 01/15/2019
• 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