MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO INTERLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C7557

Device Problem Cut In Material (2454)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/22/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).The device was received and evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the blue slide clamp of a vented paclitaxel set severed the tubing which resulted in a leak.The slide clamp severed the tubing during patient setup.The line had been primed and the patient was connected for therapy when the severed tubing was identified.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional, pressure and clear passage under water testing were performed and the device was found to be within the product specification range.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SOLUTION ADMINISTRATION SETS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 7432504
• MDR Text Key: 105533186
• Report Number: 1416980-2018-02158
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412036373
• UDI-Public: (01)00085412036373
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K160007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Pharmacist
• Type of Report: Initial,Followup
• Report Date: 05/17/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/16/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/23/2021
• Device Catalogue Number: 2C7557
• Device Lot Number: R16H23098
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/03/2018
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: DEXTROSE
• Patient Age: 62 YR