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 Particulates (1451)

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

Event Date 04/13/2022

Event Type  malfunction  

Event Description

The event involved a primary plum set which was reported to have foreign matter found in drip chamber.It was not reported whether there was patient involvement or not, however, no harm was reported as a consequence of this event.

Manufacturer Narrative

The device is expected to be returned for evaluation, however, it is yet to be received.

Manufacturer Narrative

One used list #14687-15, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot #unknown was returned for evaluation.The reported condition of foreign matter found in drip chamber was able to be confirmed.Due to the size and crushed particles it was unable to be determined the type of the particles, however, it appeared to be grease.Probable cause was determined to be due to the molding manufacturing process because the grease is used in the tools as lubricants, and it could cause the particles.A lot history review could not be conducted because no lot number(s) was/were identified.Additional information a5 and a6; d9 - the device was received 5/20/22.

• 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: 14337892
• MDR Text Key: 291229736
• Report Number: 9615050-2022-00089
• Device Sequence Number: 1
• Product Code: FPA
• 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,Followup
• Report Date: 04/13/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 1468728
• Device Catalogue Number: 14687-15
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/09/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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