MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 1.0ML 31GA 6MM 10BAG 500CS; PISTON SYRINGE

Model Number 324912

Device Problem Defective Device (2588)

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

Event Date 02/07/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that a syringe 1.0ml 31ga 6mm 10bag 500cs was damaged before use.The following was reported by the initial reporter: "it was reported that the consumer found one syringe with a crushed plunger cap.Verbatim: consumer reported finding one syringe last night with a crushed plunger cap.Consumer did not use this syringe.Lot # 0097219d.Cat #324912.Date of event: (b)(6) 2021.Samples: yes, sending mail kit".

Event Description

It was reported that a syringe 1.0ml 31ga 6mm 10bag 500cs was damaged before use.The following was reported by the initial reporter: "it was reported that the consumer found one syringe with a crushed plunger cap.Verbatim: consumer reported finding one syringe last night with a crushed plunger cap.Consumer did not use this syringe.Lot # 0097219, dcat #: 324912, date of event: 2/7/21.Samples: yes, sending mail kit.".

Manufacturer Narrative

H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.A review of the device history record was completed for batch # 0097219.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.There were two (2) notifications noted for raised caps.

• Brand Name: SYRINGE 1.0ML 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: 11422114
• MDR Text Key: 241537724
• Report Number: 1920898-2021-00269
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 00382903249121
• UDI-Public: 00382903249121
• 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: 04/30/2021

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: 324912
• Device Catalogue Number: 324912
• Device Lot Number: 0097219
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/08/2021
• Initial Date FDA Received: 03/05/2021
• Supplement Dates Manufacturer Received: 04/30/2021
• Supplement Dates FDA Received: 05/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1