MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE SYRINGE 0.3ML 29GA 1/2IN 7BAG 420CAS JP; PISTON SYRINGE

Catalog Number 326631

Device Problem Leak/Splash (1354)

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

Event Date 01/29/2021

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 0.3ml 29ga 1/2in 7bag 420cas jp separated from the hub during use.The following was reported by the initial reporter: "the customer reported about needle/shield separation from the barrel when removing the shield.Photo will be attached when it becomes available.".

Manufacturer Narrative

H.6.Investigation: no samples were returned therefore the investigation was performed based on the photos provided.Two photos of 1 loose 0.3ml bd insulin syringe were provided.The customer reported about needle/shield separation from the barrel when removing the shield.The photos were examined, and it was observed that the needle hub/shield assembly was separated from the barrel, and the cannula shield was not fully seated on the hub.Due to the batch being unknown, no dhr review can be completed.Capa#1630423 was initiated.H3 other text : see h.10.

Event Description

It was reported that a syringe 0.3ml 29ga 1/2in 7bag 420cas jp separated from the hub during use.The following was reported by the initial reporter: "the customer reported about needle/shield separation from the barrel when removing the shield.Photo will be attached when it becomes available.".

• Brand Name: SYRINGE 0.3ML 29GA 1/2IN 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: 11377899
• MDR Text Key: 233471618
• Report Number: 1920898-2021-00219
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 05/03/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/25/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 326631
• Device Lot Number: 0160988
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1