MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION INTERLINK SYSTEM SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number FNC2110

Device Problem Product Quality Problem (1506)

Patient Problem No Patient Involvement (2645)

Event Date 01/07/2020

Event Type  malfunction  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported two interlink system solution sets appeared to have "loose pieces in packaging". This issue was identified during setup. There was no patient involvement. No additional information is available.

Manufacturer Narrative

Additional information was added: two (2) devices were received for evaluation. A visual inspection was performed, and it was noted that one of the returned samples was a complete set with no abnormalities observed. The second returned sample was an incomplete set with the tubing cut approximately 50 cm away from the drip chamber. During the investigation it was established that the second returned sample was cut at a cross-cutter station during the assembly process. The tubing was dislodged from the blister pocket and cut at the cross-cutter station during assembly. The reported condition was not verified for sample one; however, was verified for the second returned sample. The cause of the reported condition was a manufacturing issue. Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK SYSTEM
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 9653649
• MDR Text Key: 177357840
• Report Number: 1416980-2020-00310
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig

Reporter Occupation

• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2020

1 Device was Involved in the Event

0 Patients were Involved in the Event:

• Date FDA Received: 01/31/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: FNC2110
• Device Lot Number: SR19G07085
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2020
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 03/26/2020
• 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: Unkown