MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE; PISTON SYRINGE

Model Number 328509

Device Problem Material Separation (1562)

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

Event Date 06/20/2023

Event Type  malfunction  

Event Description

It was reported the bd insuline syringe needle and hub separated.The following information was provided by the initial reporter: verbatim: consumer reported needle hub separated.Consumer also reported thumb press damaged.Problem involves 1 syringe from a sealed bag.

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 04-aug-2023.H6: investigation summary customer returned (1) 0.5ml 31ga 8mm loose syringe in an open polybag.It was reported by the consumer that needle hub separated.The hub separated easily and was stuck in the shield.A review of the device history record was completed for batch# 1291676.All inspections and challenges were performed per the applicable operations qc specifications.

Event Description

It was reported the bd insuline syringe thumb press broke.The following information was provided by the initial reporter: verbatim: consumer reported needle hub separated.Consumer also reported thumb press damaged/broken.Problem involves 1 syringe from a sealed bag.

• Brand Name: BD INSULIN SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer (Section G): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• Manufacturer Contact: phillip emmert ; 5859 farinon drive; san antonio, TX 78249 ; 8448235433
• MDR Report Key: 17318235
• MDR Text Key: 319286348
• Report Number: 1920898-2023-00442
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00681131311762
• UDI-Public: (01)00681131311762
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K190054
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 10/12/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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: 1291676
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/20/2023
• Initial Date FDA Received: 07/13/2023
• Supplement Dates Manufacturer Received: 10/12/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/18/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1