MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS; PISTON SYRINGE

Model Number	328411
Medical Device Problem Code	Delivered as Unsterile Product (1421)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	06/22/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.This is the 1st related complaint for the reported lot number.A review of the manufacturing records was performed and no non-conformances were raised in association with this type of event for this lot.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.
Event or Problem Description
It was reported that the syringe 1.0ml 30ga 1/2in uf 10bag 500cs caps separated from the syringe, exposing the needle.The following information was provided by the initial reporter: "the complaint is that they reached in the box to get another bag (sleeve) of syringes and was stabbed by the needle because they lids were not secure on the syringe in this one sleeve.They were unable to use the product.".

• Brand Name: SYRINGE 1.0ML 30GA 1/2IN UF 10BAG 500CS
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12194203
• Report Number: 1920898-2021-00783
• Device Sequence Number: 3509418
• Product Code: FMF
• UDI-Device Identifier: 00382908411035
• UDI-Public: 00382908411035
• Combination Product (Y/N): N
• Initial Reporter State: NC
• 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
• Report Date (Section B): 07/01/2021

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: Other
• Device Expiration Date: 09/30/2025
• Device Model Number: 328411
• Device Catalogue Number: 328411
• Device Lot Number: 0265123
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/21/2021
• Initial Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1