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

Catalog Number 328468

Device Problem Material Separation (1562)

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

Event Date 08/19/2021

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that 1 bd syringe 0.5ml 31ga 8mm hub separated from the device.The following information was provided by the initial reporter : the consumer reported that the needle shields are hard to remove prior to injection and when pulled hard on the needle shield the needle hub separates.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: h6: investigation summary customer returned (8) loose 0.5ml bd insulin syringes.The consumer reported the needle shields are hard to remove prior to injection, and stated when he pulls hard on the needle shield the needle hub separates.All 8 returned syringes were examined, and it was observed that 6 were returned without a needle hub/shield assembly attached to the barrel.No damage to the barrel tips was observed.The remaining 2 syringes were tested to determine the shield removal force (specs: shield removal force for 0.5 ml syringe after sterilization is 0.85 to 5.95lbs) and the following was observed: sample number shield removal force (lbs) sample 1 3.22 sample 2 3.08 both syringes tested within specification.A review of the device history record was completed for batch# 1060385.All inspections and challenges were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was able to duplicate or confirm the customer¿s indicated failure needle hub separates.Capa pr1630423 has been opened to address this issue.H3 other text : see h10.

Event Description

It was reported that 1 bd syringe 0.5ml 31ga 8mm hub separated from the device.The following information was provided by the initial reporter : the consumer reported that the needle shields are hard to remove prior to injection and when pulled hard on the needle shield the needle hub separates.Date of event : unknown.Samples : yes.

• Brand Name: BD SYRINGE 0.5ML 31GA 8MM
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 12477531
• MDR Text Key: 272945271
• Report Number: 1920898-2021-00994
• Device Sequence Number: 1
• Product Code: FMF
• 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: 09/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328468
• Device Lot Number: 1060385
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/13/2021
• Date Manufacturer Received: 09/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1