MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD SYRINGE 1.0ML 6MM 90 BX 450 MO; PISTON SYRINGE

Model Number 324908

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

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/14/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: samples were received and an investigation was performed.This is the 2nd complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Visual inspection of the picture found two spots of adhesive on the cannula, one near the tip, and the other further down.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.There were no quality notification or maintenance dispatches created for this issue during the production of this batch.Root cause cannot be determined.

Event Description

It was reported when using the bd syringe 1.0ml 6mm 90 bx 450 mo, the device experienced foreign matter on the device cannula, within the fluid path.This event occurred twice.The following information was provided by the initial reporter.The customer stated: it was reported that it was hard to get needle to go into insulin vial and into skin.Verbatim: from phone call on 2020-10-16 10:43:01: consumer called due to email request he received from bd rep.Stated he initially had 2 syringes where the needle was hard to push into his injection site.Stated last night (10-15-20) he now had a 3rd syringe that wouldn't puncture his skin at all.Email received¿2020-10-14 14:18:52.I have had 2 so far from this box, i didn't get a pic of the first one but it was about f to the same.I notice it was hard to get to go into insulin bottle.

• Brand Name: BD SYRINGE 1.0ML 6MM 90 BX 450 MO
• 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: 12555057
• MDR Text Key: 274067600
• Report Number: 1920898-2021-01030
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249084
• UDI-Public: 00382903249084
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/29/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/30/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 03/31/2024
• Device Model Number: 324908
• Device Catalogue Number: 324908
• Device Lot Number: 9070693
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/11/2019
• 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