MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 31GA 6MM 10BAG 500CS; PISTON SYRINGE

Model Number 324911

Device Problem Defective Device (2588)

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

Event Date 04/19/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that the syringe 0.5ml 31ga 6mm 10bag 500cs experienced product damage while still considered operable.The following information was provided by the initial reporter: material no.324911 batch no.0034888.Consumer reported found 4 syringe when removed needle shield the needle tips missing - discarded.Consumer reported found 1 syringe without a thumb press when removed plunger cap.Plunger cap is damaged.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: 5/24/2021 h.6.Investigation: customer returned (1) loose 0.5ml bd insulin syringe with an opened polybag from lot# 0034888.Consumer reported found 4 syringe when removed needle shield the needle tips missing and 1 syringe without a thumb press when removed plunger cap; plunger cap is damaged.The returned sample was examined, and it was observed that the plunger rod was broken nearest the thumb press, and the plunger cap was damaged.It was observed that the cannula was intact in the cannula hub assembly attached to the syringe barrel.The alleged defect was not observed, and therefore could not be confirmed.A review of the device history record was completed for batch# 0034888.All inspections and challenges were performed per the applicable operations qc specifications.There was one (1) notification noted that did not pertain to the complaint.Root cause for these defect cannot be determined.H3 other text : see h.10.

Event Description

It was reported that the syringe 0.5ml 31ga 6mm 10bag 500cs experienced product damage while still considered operable.The following information was provided by the initial reporter: material no.324911 batch no.0034888.Consumer reported found 4 syringe when removed needle shield the needle tips missing - discarded consumer reported found 1 syringe without a thumb press when removed plunger cap.Plunger cap is damaged.Date of event unknown.

• Brand Name: SYRINGE 0.5ML 31GA 6MM 10BAG 500CS
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11838671
• MDR Text Key: 251212769
• Report Number: 1920898-2021-00565
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249114
• UDI-Public: 00382903249114
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/17/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Model Number: 324911
• Device Catalogue Number: 324911
• Device Lot Number: 0034888
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/24/2021
• Date Manufacturer Received: 05/28/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1