MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31G 6MM S/C U-100 RELION; PISTON SYRINGE

Model Number 328519

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

Patient Problem Hypersensitivity/Allergic reaction (1907)

Event Date 03/25/2021

Event Type  malfunction  

Manufacturer Narrative

Medical device expiration date: na.Date received by manufacturer: bd was initially made aware of this complaint on (b)(6) 2021.At that time, based on the information provided by the initial reporter, it was evaluated as a non-reportable incident.Additional information was later received on 2021-05-04 that changed the reportability determination.Based on the additional information received, this complaint is now considered to be an mdr reportable incident.Investigation summary: customer returned a total of 5 syringes featuring 1.0ml graduation markings but no pouches for identification.Each sample was inspected to ensure that using the syringe was as least harmful as intended.The outer diameters of these needles were measured, the results of which are featured below: 1.0.0104 in, 2.0.0103 in, 3.0.0104 in, 4.0.0127 in, 5.0.0141 in.Two of the needles were measured outside of acceptable outer diameters for 31 gauge needles (0.0100 in to 0.0105 in).Each of the needle tips were visually inspected.The two needles outside of spec were found to have a clear, rubbery globule of material on them.The needles were inspected under uv light and both globules were blue in color.This material is believed to be the adhesive used to fasten the syringe¿s components together.No other defects were found during inspection.A review of the device history record was completed for batch# 9350453.All inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.On 27 apr 2021, holdrege received a photo complaint sample for adhesive on tip of the cannula on syringe 1.0ml 31ga 6mm s/c u-100 relion from cat: 328519, batch 9350453.Visual inspection of the picture found rundown of adhesive at the barrel tip and splatter on the tip, and the other further down on the cannula.Process summary: this operation assembles the cannula into the barrel tip and applies adhesive to hold the cannula in the barrel tip.The racks of cannulated barrels then travel through an oven which uses ir light to facilitate adhesive run down and ultraviolet light to cure the adhesive that bonds the cannula to the barrel tip.The cannulated barrels are then conveyed to a machine that inspects for missing cannula, cannula height, point quality, zero line placement, and uv adhesive.It also supplies lube to the cannula, features two lumen blows, assembles the shield to the barrel/cannula assembly, and detects for missing shields.Investigation conclusion: bd was able to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.Root cause description: verified l2l (maintenance records), dhr records & quality notifications, did not identify any root-cause.There were zero (0) notifications noted that pertained to the complaint.Rationale: based on the above, no additional investigation and no corrective/preventative action (capa) or situational analysis (sa) is required at this time.

Event Description

It was reported that syringe 1.0ml 31g 6mm s/c u-100 relion had excessive adhesive.The following information was provided by the initial reporter: material no.328519.Batch no.9350453.It was reported that it feels like needles are ripping through skin and is seeing lumps under skin.Verbatim: relion consumer stated, when taking injections, it feels like the needle is "ripping through skin".Reported, seeing "lumps" under skin.Stated, does not re-use and rotates injection sites.

• Brand Name: SYRINGE 1.0ML 31G 6MM S/C U-100 RELION
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 11787663
• MDR Text Key: 249518075
• Report Number: 1920898-2021-00529
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K170386
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/06/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328519
• Device Catalogue Number: 328519
• Device Lot Number: 9350453
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/04/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/20/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1