MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH; SET, ADMINISTRATION, INTRAVASCULAR

Model Number 1468728

Device Problem Material Integrity Problem (2978)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/26/2023

Event Type  Injury  

Event Description

The event involved a primary plum set, clave secondary port, clave y-site, secure lock, 103 inch.The reporter stated there was a crack on tubing.The reporter stated that the drug could not be injected into the patient due to a rupture of catheter, which caused patient discomfort or inability to control their condition, and had to extend their hospital stay.There was patient involvement and no report of patient harm.

Manufacturer Narrative

Received one used.List #14687-15, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #7880757, and one photo showing the device with an indicator showing the cut in the tubing.The complaint of leakage and cut tubing can be confirmed on the returned one used.List #14687-15, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #7880757.As received there was a cut in the tubing.The cut was in the shape of a v that was a straight clean cut.There was no other damages or anomalies noted.The manufacturing process was reviewed and there are no sharp objects or instruments on the manufacturing floor capable of the observed damage as a preventative measure.The probable cause of the damage observed to the tubing and packaging is due to a sharp instrument.This would have occurred outside of icu medical possession.The lot history was reviewed, no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: PRIMARY PLUM SET, CLAVE SECONDARY PORT, CLAVE Y-SITE, SECURE LOCK, 103 INCH
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: michael visocnik ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 16962803
• MDR Text Key: 315571374
• Report Number: 9615050-2023-00145
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10887787005650
• UDI-Public: (01)10887787005650(17)251001(10)7880757
• Combination Product (y/n): N
• Reporter Country Code: TW
• PMA/PMN Number: K141789
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 03/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 1468728
• Device Catalogue Number: 14687-15
• Device Lot Number: 7880757
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2023
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/13/2023
• Initial Date FDA Received: 05/19/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization