MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM UFII; PISTON SYRINGE

Model Number 328468

Device Problem Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/16/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is pending but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1 syringe 0.5ml 31ga 8mm ufii hub separated.The following information was provided by the initial reporter: the consumer stated the needle hub detached from needle and the needle is stuck in the shield.Date of event: unknown.Samples: available.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-07-13.H6: investigation summary: customer returned a single syringe with a pouch identifying it as a 0.5ml, 31 gauge, 8mm syringe from lot 1011586.The syringe has had its needle shield and hub separate from the barrel.The hub has become lodged inside the shield.There is no damage to either the connector at the distal tip of the barrel or its respective needle hub.No signs of use and no other defects found.A review of the device history record was completed for batch# 1011586.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.Based on the samples received, bd was able to confirm the customer¿s indicated failure of needle hub separation.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Capa pr1630423 has been opened to address this issue.H3 other text : see h10.

Event Description

It was reported that 1 syringe 0.5ml 31ga 8mm ufii hub separated.The following information was provided by the initial reporter : the consumer stated the needle hub detached from needle and the needle is stuck in the shield.Date of event: unknown; samples: available.

• Brand Name: SYRINGE 0.5ML 31GA 8MM UFII
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12178026
• MDR Text Key: 262650296
• Report Number: 1920898-2021-00761
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908468039
• UDI-Public: 00382908468039
• Combination Product (y/n): N
• PMA/PMN Number: K024112
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 07/16/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328468
• Device Catalogue Number: 328468
• Device Lot Number: 1011586
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 07/16/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1