MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 31GA 8MM; PISTON SYRINGE

Model Number 328440

Device Problem Material Separation (1562)

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

Event Date 06/07/2021

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 0.3ml 31ga 8mm hub separated.The following information was provided by the initial reporter :   the consumer reported that when the needle shield was removed the needle hub separated.Date of event: unknown samples: yes.

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 (3) loose 0.3ml bd insulin syringes.Consumer reported, when she removed needle shield needle hub separated, and needle shields are hard to remove.The returned samples were examined, and it was observed that two syringes featured a detached hub assembly.No damage to either barrel tip was observed.The remaining syringe was tested to determine the shield removal force (specs: shield removal force for 0.3 ml syringe after sterilization is 0.85 to 5.95lbs) and measured within specification at 5.09 lbs; hub separation was not observed on this sample.A review of the device history record was completed for batch# 0293915.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.Bd was able to confirm the customer¿s indicated failure 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 0.3ml 31ga 8mm hub separated.The following information was provided by the initial reporter: the consumer reported that when the needle shield was removed the needle hub separated.Date of event: unknown.Samples: yes.

• Brand Name: SYRINGE 0.3ML 31GA 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12104752
• MDR Text Key: 262694258
• Report Number: 1920898-2021-00718
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382908440035
• UDI-Public: 00382908440035
• 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: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328440
• Device Catalogue Number: 328440
• Device Lot Number: 0293915
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/13/2021
• Date Manufacturer Received: 07/07/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1