MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE; PISTON SYRINGE

Catalog Number 328438

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/04/2020

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 15 bd insulin syringe with bd ultra-fine¿ needles experienced hub separation from the device.The following information was provided by the initial reporter: material no: 328438 batch no: 0132200.Consumer reported when removed the shield and needle was missing 15 found.Not hard to remove shield.But something inside the shield.

Event Description

It was reported that 15 bd insulin syringe with bd ultra-fine¿ needles experienced hub separation from the device.The following information was provided by the initial reporter: material no: 328438 batch no: 0132200 consumer reported when removed the shield and needle was missing 15 found.Not hard to remove shield.But something inside the shield.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: (b)(6) 2021.Investigation summary : customer returned (3) loose 0.3ml bd insulin syringes.Consumer reported when removed the shield the needle was missing.All 3 returned syringes were examined, and it was observed that 2 syringes exhibited a separated needle hub/shield assembly; no damage to the barrel tips was observed.The third syringe did not exhibit hub separation; removing the cannula shield from this syringe did not result in hub separation.A review of the device history record was completed for batch # 0132200 all inspections were performed per the applicable operations qc specifications.There was one(1) notification (b)(4) noted for out of spec shield pulls.Bd was able to confirm the customer¿s indicated failure the shield the needle was missing.Root cause for this defect cannot be determined.Capa1630423 has been opened to address this issue.

• Brand Name: BD INSULIN SYRINGE WITH BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11103511
• MDR Text Key: 259026055
• Report Number: 1920898-2020-01787
• 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: 02/05/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 328438
• Device Lot Number: 0132200
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/11/2021
• Date Manufacturer Received: 02/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1