MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD ULTRA-FINE INSULIN SYRINGE AND NEEDLE; HYPODERMIC SYRINGE AND NEEDLE

Catalog Number 328325

Device Problem Device Contamination with Chemical or Other Material (2944)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 12/13/2017

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 Description

It was reported that a hard plastic piece of foreign matter was found in the barrel of the bd ultra-fine insulin syringe and needle.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: one (1) 1/2cc, 8mm, 30g syringe was returned in an open poly bag from lot # 6179912.Customer states that there was a hardened plastic inside the syringe barrel.The returned syringe was examined and exhibited a loose, hard piece of material inside the barrel.A small portion of this material was removed from the sample and prepared for ftir spectral analysis.The spectral analysis suggests that this material has components similar to those of polypropylene.As per manufacturing, a review of the device history record was completed for batch# 6179912.All inspections and challenges were performed per the applicable operations qc specifications.Based on the samples / photo(s) received the investigation concluded: confirmed: bd was able to duplicate or confirm the customer¿s indicated failure mode.Investigation conclusion: 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: BD ULTRA-FINE INSULIN SYRINGE AND NEEDLE
• Type of Device: HYPODERMIC SYRINGE AND NEEDLE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7154832
• MDR Text Key: 96124150
• Report Number: 1920898-2017-00413
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 02/26/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 07/31/2021
• Device Catalogue Number: 328325
• Device Lot Number: 6179912
• Date Manufacturer Received: 12/13/2017
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR