MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE INTERLINK; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number A2N3371

Device Problems Break (1069); Reflux within Device (1522)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/09/2018

Event Type  malfunction  

Manufacturer Narrative

The device was received for evaluation.The sample was received without pouch.The returned set was connected to a non-baxter (bd) threaded lock cannula.Visual inspection was performed via naked eye for visual defect and found injection site to female luer lock joint was broken, and the broken stem was remained bonded with female luer lock.Functional testing could not be performed, so the reported backflow could not be verified.The reported issue of damaged was verified.The cause was not determined.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that there was a backflow of blood through an access catheter extension set, and that there was "damage to the cap".This was noticed during patient use.There was no patient injury or medical intervention.No additional information is available.

Manufacturer Narrative

The blood backflow was observed ten (10) hours after starting infusion.The medication that was infused is dexmedetomidine.Dexmedetomidine, therapy date (b)(6) 2018.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: INTERLINK
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• 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: 7958611
• MDR Text Key: 123520090
• Report Number: 1416980-2018-06504
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/05/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: A2N3371
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/03/2018
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/14/2018
• Initial Date FDA Received: 10/11/2018
• Supplement Dates Manufacturer Received: 11/09/2018
• Supplement Dates FDA Received: 12/05/2018
• 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: N
• Patient Sequence Number: 1