MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE; PISTON SYRINGE

Model Number	928856
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Investigation summary: customer returned a total of 14 syringes and a pouch labeled for 1.0ml, 31 gauge, 8mm syringes from lot 0232158.Each sample was inspected to ensure that using the syringe was as least harmful as intended.However, during visual inspection, adhesive was found along the outer diameter of all of the needle cannulas.The clear, rubbery drops found on each needle made it difficult to measure the needles¿ diameters.The needles were inspected under uv light to confirm that the substance found was indeed 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# 0232158.All inspections were performed per the applicable operations qc specifications.There was one (1) notification [200893686] noted that did not pertain to the complaint.Based on the samples received, bd was able to confirm the customer¿s indicated failure of blunt needles.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.Manufacturing (holdrege) will be notified of this issue.On (b)(6) 2021, holdrege received a photo complaint sample for adhesive splatter on syringe 1.0ml 31ga 8mm, batch: 0232158 and catalog number: 928856.Visual inspection of the picture found splatter of adhesive on the cannula on multiple syringes.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.Reviewed l2l maintenance logs, log books and if any machine changes occurs, did not identify any changes.There was one (1) notification [200893686] noted that did not pertain to the complaint.Therefore, could not determine a root-cause.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that excessive adhesive was found on the bd insulin syringe needle during the inspection.The following information was provided by the initial reporter: "consumer reported needles dull, not smooth and will not penetrate the skin." via bd investigation: "customer returned a total of 14 syringes and a pouch labeled for 1.0ml, 31 gauge, 8mm syringes from lot 0232158.Each sample was inspected to ensure that using the syringe was as least harmful as intended.However, during visual inspection, adhesive was found along the outer diameter of all of the needle cannulas.The clear, rubbery drops found on each needle made it difficult to measure the needles¿ diameters.The needles were inspected under uv light to confirm that the substance found was indeed adhesive used to fasten the syringe¿s components together.No other defects were found during inspection.

• Brand Name: BD INSULIN SYRINGE
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11828812
• Report Number: 1920898-2021-00556
• Device Sequence Number: 1059257
• Product Code: FMF
• UDI-Device Identifier: 00311917048130
• UDI-Public: 00311917048130
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K170386
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date (Section B): 05/14/2021

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 Expiration Date: 08/31/2025
• Device Model Number: 928856
• Device Catalogue Number: 928856
• Device Lot Number: 0232158
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1