MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL; PISTON SYRINGE

Model Number 328509

Device Problem Break (1069)

Patient Problem Foreign Body In Patient (2687)

Event Date 10/22/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.Medical device expiration date: na.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 two syringe 0.5ml 31ga 8mm 10 bag 500 wal experienced the cannula breaking off, or pulling out.The following information was provided by the initial reporter: consumer reported that the needle broke off in the injection site during injection, consumer was able to remove the needle with her fingers, no medical attention, no injury.Also reported needle missing from 3 syringes and needle brake before injection.Consumer does not reuse.Lot #: 9322390; catalog #: 328509; date of event: unknown.

Manufacturer Narrative

The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/4/2020.H.6.Investigation: customer returned (4) loose 3/10cc syringe.Customer states that the needle broke off in injection site and the needle was missing from 3 syringes and needle broke off before injection.All returned syringes were examined and all were returned without the hub-needle/shield assembly.A review of the device history record was completed for batch# 9322390.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200861364, 200851631] noted that did not pertain to the complaint.Confirmed: bd was able to duplicate or confirm the customer¿s indicated failure (hub separates).Unconfirmed: bd was not able to duplicate or confirm the customer¿s indicated failure (broken needle).Root cause: root cause for this defect cannot be determined.Capa#1630423 was initiated.H3 other text : see h.10.

Event Description

It was reported that two syringe 0.5ml 31ga 8mm 10 bag 500 wal experienced the cannula breaking off or pulling out.The following information was provided by the initial reporter: consumer reported that the needle broke off in the injection site during injection, consumer was able to remove the needle with her fingers, no medical attention, no injury.Also reported needle missing from 3 syringes and needle brake before injection.Consumer does not reuse.Lot #: 9322390.Catalog #: 328509.Date of event: unknown.

• Brand Name: SYRINGE 0.5ML 31GA 8MM 10 BAG 500 WAL
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 10852455
• MDR Text Key: 218680292
• Report Number: 1920898-2020-01580
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311762
• UDI-Public: 00681131311762
• 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: 12/17/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/17/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 328509
• Device Catalogue Number: 328509
• Device Lot Number: 9322390
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/04/2020
• Date Manufacturer Received: 12/17/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1