MAUDE Adverse Event Report: NATIONAL MEDICAL PRODUCTS, INC. J-TIP; INJECTOR, FLUID, NON-ELECTRICALLY POWERED

Lot Number 190224-040

Device Problem Crack (1135)

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

Event Date 03/05/2019

Event Type  malfunction  

Event Description

Lidocaine 1% buffered 1% injection (j-tip) was used on a patient for a peripheral iv start.Upon activation of the device to administer the drug the syringe cracked.

• Brand Name: J-TIP
• Type of Device: INJECTOR, FLUID, NON-ELECTRICALLY POWERED
• Manufacturer (Section D): NATIONAL MEDICAL PRODUCTS, INC.; 57 parker st.; irvine CA 92618
• MDR Report Key: 8686578
• MDR Text Key: 147588655
• Report Number: 8686578
• Device Sequence Number: 1
• Product Code: KZE
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 04/01/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/11/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: 190224-040
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/01/2019
• Date Report to Manufacturer: 06/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 4015 DA