MAUDE Adverse Event Report: NIPRO IV CATHETER

NIPRO IV CATHETER

Model Number	CI+2225-2C
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
Date of occurrence is unknown: customer reported 2 incidents where the catheter broke upon insertion to the patient.No injuries, medical interventions or hospitalization.After opening 1 box, several catheters were found with the clear and blue outer casing broken.

Search Alerts/Recalls

1 Device was Involved in the Event
Brand Name	NIPRO IV CATHETER
Common Device Name	IV CATHETER
MDR Report Key	12309402
Report Number	9610987-2021-00009
Device Sequence Number	11731033
Product Code	FOZ
UDI-Device Identifier	00383790006408
UDI-Public	00383790006408
Combination Product (Y/N)	N
Initial Reporter State	AR
Initial Reporter Country	US
PMA/510(K) Number	K960051
Number of Events Summarized	1
Summary Report (Y/N)	N
Serviced by Third Party (Y/N)	N
Reporter Type	Manufacturer
Report Source	distributor
Initial Reporter Occupation	Other Health Care Professional
Type of Report	Initial
Report Date (Section B)	08/11/2021
1 Patient was Involved in the Event
Is this an Adverse Event Report?	No
Is this a Product Problem Report?	Yes
Operator of Device	Health Professional
Device Expiration Date	03/31/2025
Device Model Number	CI+2225-2C
Device Lot Number	20D10C
Was Device Available for Evaluation?	Device Returned to Manufacturer
Date Returned to Manufacturer	07/27/2021
Type of Report(Section G)	Initial
Initial Date Received by Manufacturer	07/22/2021
Initial Report FDA Received Date	08/11/2021
Was Device Evaluated by Manufacturer? (Y/N)	Yes
Date Device Manufactured	04/10/2020
Is the Device Labeled for Single Use? (Y/N)	Yes
Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N)	No
Usage of Device	Initial
Patient Sequence Number	1
Outcome Attributed to Adverse Event	Other;