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

Catalog Number 324917

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

Event Type  malfunction  

Manufacturer Narrative

"date of event: unknown.The date received by manufacturer has been used for this field.Initial reporter phone: (b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.(b)(4).".

Event Description

It was reported that an unspecified number of syringe 0.5ml 31ga 6mm 10 bag 500 sla separated from the hub during use.The following was reported by the initial reporter: "reports that when removing the orange safety shield, the needle and the hub have separated from the syringe, and have gotten stuck inside the safety shield.".

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# 9350257.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications [200869607, 200869050] noted that did not pertain to the complaint.H3 other text : see h.10.

Event Description

It was reported that an unspecified number of syringe 0.5ml 31ga 6mm 10 bag 500 sla separated from the hub during use.The following was reported by the initial reporter: "reports that when removing the orange safety shield, the needle and the hub have separated from the syringe, and have gotten stuck inside the safety shield.".

• Brand Name: SYRINGE 0.5ML 31GA 6MM 10 BAG 500 SLA
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11386090
• MDR Text Key: 233785932
• Report Number: 1920898-2021-00234
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/26/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 324917
• Device Lot Number: 9350257
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/24/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 62 YR