MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE; 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	04/19/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that 2 bd¿ insulin syringes would not draw up insulin during use.The following information was provided by the initial reporter: "consumer reported found 2 syringes that would not draw up insulin".
Event or Problem Description
It was reported that 2 bd¿ insulin syringes would not draw up insulin during use.The following information was provided by the initial reporter: "consumer reported found 2 syringes that would not draw up insulin".
Additional Manufacturer Narrative
H6: investigation summary: customer returned (2) 0.3ml insulin syringes from lot# 0125322.Consumer reported found 2 syringes that would not draw up insulin.Both returned samples were examined, then tested for flow: both syringes were unable to draw properly.A wire test was then performed on these 2 samples: the wire was able to pass through the cannula of both syringes, and it was observed that a small, clear residue was at the tip of the wire after being through both cannulas.Under the microscope the residue from both cannula was identified as residual silicone from the manufacturing process.The dislodged residue could not be extracted from either sample.After performing the wire test both syringes were able to draw and expel properly.A review of the device history record was completed for batch# 0125322.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure (clog).H3 other text : see h10.

• 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: 11842978
• Report Number: 1920898-2021-00572
• Device Sequence Number: 14611104
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/14/2021

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: 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: 05/03/2021
• Initial Date Received by Manufacturer: 04/20/2021
• Supplement Date Received by Manufacturer: 06/14/2021
• Initial Report FDA Received Date: 05/18/2021
• Supplement Report FDA Received Date: 06/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1