MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.5ML 30GA 8MM 7BAG 420CAS JP; PISTON SYRINGE

Catalog Number 326668

Device Problem Defective Device (2588)

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

Event Date 01/06/2021

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.(b)(4).

Event Description

It was reported that a syringe 0.5ml 30ga 8mm 7bag 420cas jp was damaged before use.The following was reported by the initial reporter: "the distributor discovered that the shield was separated from the barrel in a polybag.".

Manufacturer Narrative

H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.Two photos of a polybag for 0.5ml bd insulin syringes was provided.The customer reported that the shield was separated from the barrel in a polybag.The photos were examined, and it was observed that the cannula shield for one of the syringes inside the polybag was not attached, leaving the cannula exposed; the cannula shield was loose inside the polybag.A review of the device history record was completed for batch# 0125276.All inspections and challenges were performed per the applicable operations qc specifications.There were two (2) notifications noted that did not pertain to the complaint.There were two (2) notifications noted for out of spec shield pulls.Capa#1630423 has been opened to address this issue h3 other text : see h.10.

Event Description

It was reported that a syringe 0.5ml 30ga 8mm 7bag 420cas jp was damaged before use.The following was reported by the initial reporter: "the distributor discovered that the shield was separated from the barrel in a polybag.Photos are attached in "attached files" in interface fields.".

• Brand Name: SYRINGE 0.5ML 30GA 8MM 7BAG 420CAS JP
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 11233849
• MDR Text Key: 241509519
• Report Number: 1920898-2021-00109
• 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: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 04/16/2021

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: Other
• Device Catalogue Number: 326668
• Device Lot Number: 0125276
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/06/2021
• Initial Date FDA Received: 01/26/2021
• Supplement Dates Manufacturer Received: 04/16/2021
• Supplement Dates FDA Received: 04/23/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1