MAUDE Adverse Event Report: BARD BARD TOOMEY SYRINGE

Model Number 0038460

Device Problem Delivered as Unsterile Product (1421)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 07/05/2017

Event Type  malfunction  

Event Description

A clear liquid substance was observed in the sterile packaging of 2 separate toomey syringes in the nicu.There is no hole or breakage in the packaging to elicit the liquid.Unknown substance.Appears to be an oily substance of some sort but also look like water droplets.

• Brand Name: BARD TOOMEY SYRINGE
• Type of Device: BARD TOOMEY SYRINGE
• Manufacturer (Section D): BARD
• MDR Report Key: 6746496
• MDR Text Key: 81288400
• Report Number: MW5071258
• Device Sequence Number: 1
• Product Code: KYZ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/26/2017

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: Health Professional
• Device Expiration Date: 04/01/2022
• Device Model Number: 0038460
• Device Lot Number: NGBR0317
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 07/26/2017
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1