MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. UNKNOWN

Catalog Number UNKNOWN

Device Problem Particulates (1451)

Patient Problem No Patient Involvement (2645)

Event Date 11/01/2019

Event Type  malfunction  

Manufacturer Narrative

The device is expected to return to the manufacturer for investigation, however, it has not been received.

Event Description

The date of the event is unknown.The event involved a report of foreign material that was found inside an unspecified icu medical arterial line with unknown list number and unknown lot number.There was no patient involved.

Manufacturer Narrative

Received one (1) used list # 14687, primary plum set, clave secondary port, clave y-site, secure lock, 103 inch; lot # 4042166 for investigation.The unknown solution residuals are observed in as received used list # 14687 set and the 69" tubing is cut near cassette-dual.As received, the used set containing prior solution residuals was separated into two segments.The segments were inspected and no foreign matter/particulate was visible anywhere in the set.Deionized water was injected into both halves of the set and the fluid was collected and filtered using a pall gn-6 metricel 0.45 um filter in a vacuum filter.The filter was examined under the microscope and no particulate was found.The reported complaint cannot be confirmed.The lot history was reviewed and there were no nonconformities which would have contributed to the reported complaint.

• Brand Name: UNKNOWN
• Type of Device: UNKNOWN
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 9343417
• MDR Text Key: 202987619
• Report Number: 9617594-2019-00395
• Device Sequence Number: 1
• Product Code: DRS
• UDI-Device Identifier: 00(01)(17)(10)
• UDI-Public: (01)(17)(10)
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1