MAUDE Adverse Event Report: NIPRO NIPRO; DISPOSABLE SYRINGE 10 CC

Lot Number 20170405

Device Problems Break (1069); Detachment Of Device Component (1104)

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

Event Date 12/08/2017

Event Type  malfunction  

Event Description

Heparin bolus was given pre tx using a nipro 10cc syringe (lot # 20170405 exp 03/31/2022) into the venous needle/line.When disconnecting syringe the middle portion of syringe broke off into the venous needle/line.Venous needle had to be pulled and patient had to be restuck.Both syringe and needle were placed in sharps container.

• Brand Name: NIPRO
• Type of Device: DISPOSABLE SYRINGE 10 CC
• Manufacturer (Section D): NIPRO; miami FL 33172
• MDR Report Key: 7104412
• MDR Text Key: 94550160
• Report Number: MW5073873
• Device Sequence Number: 1
• Product Code: FMF
• 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: 12/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2022
• Device Lot Number: 20170405
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• 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
• Patient Age: 56 YR
• Patient Weight: 47