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

Catalog Number	329461
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Needle Stick/Puncture (2462)
Date of Event	05/10/2019
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 a needle through cap occurred with a syringe 0.5ml 28ga 1/2in bls 500cas ca.The following information was provided by the initial reporter, "reapplied cap after drawing up insulin and needle came through cap and needle stick occurred.".
Event or Problem Description
It was reported that a needle through cap occurred with a syringe 0.5ml 28ga 1/2in bls 500cas ca.The following information was provided by the initial reporter: "reapplied cap after drawing up insulin and needle came through cap and needle stick occurred.".
Additional Manufacturer Narrative
H.6.Investigation: customer returned (1) 1/2cc, 12.7mm, 28g bd insulin syringes in a sealed blister pack from lot # 8085769.Customer states that they reapplied the cap after drawing up insulin and needle came through cap and needle stick occurred.The returned syringe was examined and no bent cannula or cannula through the shield was observed.No exposed cannula was observed.No defects were observed on the returned sample.A review of the device history record was completed for batch# 8085769.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.

• 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: 8659955
• Report Number: 1920898-2019-00502
• Device Sequence Number: 284632
• 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): 06/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 329461
• Device Lot Number: 8085769
• Initial Date Received by Manufacturer: 05/15/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 05/31/2019
• Supplement Report FDA Received Date: 06/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other