MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE RELION® INSULIN SYRINGE

Catalog Number 328506

Device Problems Physical Resistance (2578); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/09/2018

Event Type  malfunction  

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 Description

It was reported that the plunger rod of a relion® insulin syringe was difficult to move during an injection.It was also reported that red foreign matter was found inside the same syringe.There was no report of injury or medical intervention.

Manufacturer Narrative

Investigation results: severity: s1; occurrence: a complaint history check was performed and this is the 1st related complaint for plunger rod difficult to move and the 1st related complaint for foreign matter inside syringe on lot # 5180652.A review of the device history record was completed for batch# 5180652.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Customer returned (1) 1cc, 8mm, 31g relion syringe in an open poly bag from lot # 5180652.Customer states that the plunger rod was difficult to move during injection and a red substance was noticed inside the syringe.The syringe was returned with approximately 60 units of a reddish tinged cloudy liquid inside the barrel.This indicates that the sample was able to draw without any defects.The reddish tinge indicates that blood may have been introduced into the syringe during the injection which would not have been acquired during the manufacturing process.Bd was not able to duplicate or confirm the customer¿s indicated failure (fm and plunger difficult to move) as the reddish material would not have been acquired during the manufacturing process.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.

• Brand Name: RELION® INSULIN SYRINGE
• Type of Device: INSULIN SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 7237520
• MDR Text Key: 98996717
• Report Number: 1920898-2018-00019
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311748
• UDI-Public: 00681131311748
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,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: 02/02/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328506
• Device Lot Number: 5180652
• Date Manufacturer Received: 01/11/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other