MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number S2H8486

Device Problem Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 06/14/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter last name: (b)(6).Device manufacturer address 1: (b)(4).The actual device was not available; however, photographs of the samples were provided for evaluation.The returned photographs were reviewed, and it was observed that the sterile packaging was damaged.The reported condition was verified.The cause of the condition was due to misplacement of the roller clamp that, submitted to an external force during the distribution of the product that create enough friction to damaged or cut the packaging.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.

Event Description

During evaluation of returned photographs of two (2) clearlink system non-dehp solution sets, it was observed that the sterile packaging was damaged.There was no patient involvement.No additional information is available.

• Brand Name: CLEARLINK SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; see h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 15236833
• MDR Text Key: 302333870
• Report Number: 1416980-2022-04277
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412626017
• UDI-Public: (01)00085412626017
• Combination Product (y/n): N
• Reporter Country Code: PM
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/16/2022

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: Other
• Device Catalogue Number: S2H8486
• Device Lot Number: R22D13017
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 08/10/2022
• Initial Date FDA Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 04/13/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1