MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD 0.5ML SYRINGE; PISTON SYRINGE

Model Number	328520
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that 5 bd 0.5ml syringes were unable to inject insulin.The following information was provided by the initial reporter: consumer reported found 5 that clogged during injection.
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Additional Manufacturer Narrative
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch# 1102583.All inspections and challenges were performed per the applicable operations qc specification.There were zero (0) notifications noted that pertained to the complaint.H3 other text : see h.10.
Event or Problem Description
It was reported that 5 bd 0.5ml syringes were unable to inject insulin.The following information was provided by the initial reporter: consumer reported found 5 that clogged during injection.
Event or Problem Description
It was reported that 5 bd 0.5ml syringes were unable to inject insulin.The following information was provided by the initial reporter: consumer reported found 5 that clogged during injection.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.9.Device available for eval?: yes.D.9.Returned to manufacturer on: 1/6/2022.H.6.Investigation: customer returned (2) 0.5ml, 31 gauge, 6mm syringes from lot 1102583.The syringes were visually inspected and no defects were found.The needles had not been bent.The syringes were both used to draw water in order to test their functionality.Water could be drawn into and expelled from the syringes without issue.The syringes featured no damage and functioned as intended.A review of the device history record was completed for batch# 1102583.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Based on the samples received, bd was unable to confirm the customer¿s indicated failure of needle clogs.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h.10.

• Brand Name: BD 0.5ML SYRINGE
• Common Device Name: 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12981069
• Report Number: 1920898-2021-01298
• Device Sequence Number: 11835025
• Product Code: FMF
• UDI-Device Identifier: 00681131138369
• UDI-Public: 00681131138369
• Combination Product (Y/N): N
• Initial Reporter State: WI
• 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: Other,Consumer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/21/2022

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: 04/30/2026
• Device Model Number: 328520
• Device Catalogue Number: 328520
• Device Lot Number: 1102583
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/12/2021
• Supplement Date Received by Manufacturer: 12/15/2021; 01/21/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 01/05/2022; 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/12/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown