MAUDE Adverse Event Report: BD BD INTEGRASYRINGE 3ML-25GX5/8"; RETRACTING SYRINGE

Model Number 305269

Device Problem Component Missing (2306)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 06/27/2014

Event Type  Injury  

Event Description

Injection given needle lost into fact 25gx5/8 - 3 ml.

• Brand Name: BD INTEGRASYRINGE 3ML-25GX5/8"
• Type of Device: RETRACTING SYRINGE
• Manufacturer (Section D): BD; franklin lakes NJ 07417
• MDR Report Key: 3999607
• MDR Text Key: 4780146
• Report Number: MW5037662
• Device Sequence Number: 1
• Product Code: FMF
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/04/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/18/2018
• Device Model Number: 305269
• Device Lot Number: 3206399 CAV 11
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 46 YR
• Patient Weight: 132