MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG; PISTON SYRINGE

Model Number	928858
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that syringe 0.3ml 31ga 8mm 10bag 500 pl/wg was unable to draw up insulin.This occurred on 3 occasions.The following information was provided by the initial reporter: material no.928858 batch no.0125322.It was reported that syringes would not draw up insulin.
Event or Problem Description
It was reported that syringe 0.3ml 31ga 8mm 10bag 500 pl/wg was unable to draw up insulin.This occurred on 3 occasions.The following information was provided by the initial reporter: material no.928858 batch no.0125322.It was reported that syringes would not draw up insulin.
Additional Manufacturer Narrative
H6: investigation summary: customer returned a single syringe alongside an unopened pouch labeled for 0.3ml, 31 gauge, 8mm syringes from lot 0125322.When attempted, water could not be drawn into the separated syringe.This syringe was inspected under the microscope and no defects were immediately visible.A wire was threaded into the distal tip of the cannula.The wire reached several millimeters into the length of the cannula before stopping.The wire could not be used to dislodge the obstruction.The obstruction is likely adhesive based on its location and durability.The remaining pouch of syringes was inspected and no defects were found.All syringes in this pouch would draw fluid when tested.A review of the device history record was completed for batch# 0125322.All inspections and challenges were performed per the applicable operations qc specifications.Based on the samples received, bd was able to replicate and confirm the customer¿s indicated failure of syringes not drawing insulin in one of the eleven samples returned.Root cause cannot be determined for this complaint.H3 other text : see h10.

• Brand Name: SYRINGE 0.3ML 31GA 8MM 10BAG 500 PL/WG
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11580289
• Report Number: 1920898-2021-00359
• Device Sequence Number: 11836423
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K024112
• 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: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/23/2021

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: 05/31/2025
• Device Model Number: 928858
• Device Catalogue Number: 928858
• Device Lot Number: 0125322
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Initial Date Received by Manufacturer: 03/03/2021
• Supplement Date Received by Manufacturer: 04/23/2021
• Initial Report FDA Received Date: 03/28/2021
• Supplement Report FDA Received Date: 05/06/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1