MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. INTERN III SYSTEM SCHENKEL LINKS; STOPCOCK, I.V. SET

Catalog Number SN1071

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/16/2019

Event Type  malfunction  

Manufacturer Narrative

The device has been returned for evaluation.Testing is not complete.

Event Description

The event involved an intern iii system schenkel links that was reported that during infusion of an unspecified cytotoxic medication, various leaking splices were detected.The device was changed out/replaced with no further problems encountered.There was patient involvement and no adverse effects were reported.This report reflects 2 of 2 incidents.

Manufacturer Narrative

One used list # sn1071, intern iii system schenkel links; lot # 3917822 was returned for evaluation.The infusion set was pressure leak tested.Leakage was detected at the inlet of a bifurcated junction.The probable cause of the channel leakage was an insufficient bond in ensenada.The dhr for lot number 3917822 was reviewed and there were no relevant non-conformances found.

• Brand Name: INTERN III SYSTEM SCHENKEL LINKS
• Type of Device: STOPCOCK, I.V. SET
• 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: 9226179
• MDR Text Key: 204574127
• Report Number: 9617594-2019-00358
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00840619091071
• UDI-Public: (01)00840619091071(17)211201(10)3917822
• Combination Product (y/n): N
• PMA/PMN Number: K964435
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 07/17/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2021
• Device Catalogue Number: SN1071
• Device Lot Number: 3917822
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 10/07/2019
• Initial Date Manufacturer Received: 07/17/2019
• Initial Date FDA Received: 10/23/2019
• Supplement Dates Manufacturer Received: 10/30/2019
• Supplement Dates FDA Received: 11/07/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: UNSPEC SYRINGE, MFR UNK