MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE 1ML 31GX6MM U-100 INSULIN SYRINGE WALMART; PISTON SYRINGE

Model Number	328519
Medical Device Problem Code	Defective Device (2588)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/05/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: na.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that an unspecified number of 1ml 31gx6mm u-100 insulin syringe (b)(4) experienced broken thumb presses.Product defect was noted during use.The following information was provided by the initial reporter: consumer reported finding the needle to bend during injection with levimer 90 uts consumer reported finding the plunger thumb press to then snap and break lot # 9350453b, catalog# 328519, date of event unknown.
Additional Manufacturer Narrative
H6: investigation summary: samples were received and an investigation was performed.Visual inspection of the syringes found one with the plunger broken off inside the barrel and the top 1 ¼ inch of the plunger loose in the bag, two syringes with stress marks on the plunger, and two more syringe that did not have stress marks on the plunger.All 5 syringes had bent cannula.When the plungers were pulled out there were droplets inside of several of the syringes that indicated that the syringes were sent after being used.This is the 2nd related complaint for needle bending during use and the 1st related complaint for thumbpress breaks off during use on lot # 9350453.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Bd was able confirm the indicated issue.Based on the investigation, no additional investigation and no capa is required at this time.Process summary: the 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.The automatic syringe assembly machine feeds 1ml syringe components (barrel, stopper, plunger, and cap) and assembles these components.This machine consists of a barrel-cleaning dial, lubrication dial, one plunger/stopper assembly dial and one syringe assembly dial and various inspection and transfer dials.There were no quality notifications or maintenance dispatches during the production of these syringes that pertained to this issue.A root cause cannot be determined.
Event or Problem Description
It was reported that an unspecified number of 1ml 31gx6mm u-100 insulin syringe walmart experienced broken thumb presses.Product defect was noted during use.The following information was provided by the initial reporter: consumer reported finding the needle to bend during injection with levimer 90 uts consumer reported finding the plunger thumb press to then snap and break lot # 9350453b, catalog# 328519, date of event unknown.

• Brand Name: 1ML 31GX6MM U-100 INSULIN SYRINGE WALMART
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10738001
• Report Number: 1920898-2020-01478
• Device Sequence Number: 14209459
• Product Code: FMF
• UDI-Device Identifier: 00681131138345
• UDI-Public: 00681131138345
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/16/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: 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: 10/23/2020
• Initial Date Received by Manufacturer: 10/05/2020
• Supplement Date Received by Manufacturer: 11/16/2020
• Initial Report FDA Received Date: 10/26/2020
• Supplement Report FDA Received Date: 11/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1