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

Model Number 928858

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.Date of event: unknown.Samples: available.

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 the needle hub separated date of event: unknown samples: available.

Manufacturer Narrative

The following fields were updated due to additional information: d4: medical device lot #: 0098929.D4: medical device expiration date: 2025-04-30.H4: device manufacture date: 2020-04-07.D10: device available for eval yes.D10: returned to manufacturer on: 2021-07-13.H6: investigation summary customer returned (5) 31gx8mm, 0.3ml insulin syringes from lot# 0098929.Consumer reported that the needle hub separated.All 5 syringes were examined, and it was observed that each syringe had a needle hub/shield assembly properly attached removing each cannula shield did not result in hub separation.A review of the device history record was completed for batch # 0098929 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.A review of the device history record was completed for batch # 0006883 all inspections were performed per the applicable operations qc specifications.There were zero (0) notifications noted that pertained to the complaint.Bd was not able to duplicate or 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.Root cause cannot be determined at this time as the issue is unconfirmed.H3 other text : see h10.

• 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: 12104285
• MDR Text Key: 259595992
• Report Number: 1920898-2021-00717
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00311917048154
• UDI-Public: 00311917048154
• 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: 928858
• Device Catalogue Number: 928858
• Device Lot Number: SEE H10
• 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