MAUDE Adverse Event Report: ICU MEDICAL COSTA RICA LTD. PREPIERCED MALE ADAPTER PLUG; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 113010401

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

The complaint of particulate matter on the 113010401 could not be confirmed.No product samples, pictures, or videos were received for investigation.Without the return of the sample a comprehensive failure investigation cannot be performed and a cause cannot be determined.The dhr could not be reviewed due to the unknown lot number.

Event Description

The event occurred on an unknown date that involved a prepierced port.The customer reported that during a clinical drug trial for an unspecified drug, there were particulates in the infusion.There is no more information provided.

• Brand Name: PREPIERCED MALE ADAPTER PLUG
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL COSTA RICA LTD.; zona franca global; la aurora heredia ; CS
• Manufacturer Contact: christopher zanoni ; 600 n. field dr.; lake forest, IL 60045 ; 2247062300
• MDR Report Key: 8982466
• MDR Text Key: 157130952
• Report Number: 9615050-2019-00385
• Device Sequence Number: 1
• Product Code: FPK
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K941214
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 08/27/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 113010401
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/27/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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