MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA; PISTON SYRINGE

Model Number	329461
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that syringe 0.5ml 28ga 1/2in bls 500cas ca leaked.The following information was provided by the initial reporter: material no: 329461, batch no: 0069680 it was reported that insulin came out of the end of the syringe.Verbatim: our client bought 60 bd syringes.Of the 60 he only had about 12 that were not functional.Insulin came out of the end of the syringe.So the client lost insulin and also syringes due to this bad manufacturing.
Additional Manufacturer Narrative
H6: investigation summary: 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# 0069680.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Root cause cannot be determined at this time as the issue is unconfirmed as no samples or photos were returned.H3 other text : see h10.
Event or Problem Description
It was reported that syringe 0.5ml 28ga 1/2in bls 500cas ca leaked.The following information was provided by the initial reporter: material no: 329461 batch no: 0069680.It was reported that insulin came out of the end of the syringe.Verbatim: our client bought 60 bd syringes.Of the 60 he only had about 12 that were not functional.Insulin came out of the end of the syringe.So the client lost insulin and also syringes due to this bad manufacturing.

• Brand Name: SYRINGE 0.5ML 28GA 1/2IN BLS 500CAS CA
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11000283
• Report Number: 1920898-2020-01705
• Device Sequence Number: 4396384
• Product Code: FMF
• UDI-Device Identifier: 30382903294610
• UDI-Public: 30382903294610
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K024112
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 02/10/2021

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: 329461
• Device Catalogue Number: 329461
• Device Lot Number: 0069680
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/18/2020
• Supplement Date Received by Manufacturer: 02/03/2021
• Initial Report FDA Received Date: 12/13/2020
• Supplement Report FDA Received Date: 02/13/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1