MAUDE Adverse Event Report: CLEARLINK SECONDARY MEDICATION SET; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C7461

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 07/09/2021

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that a clearlink system secondary medication set had brown tubing and an unknown substance in the drip chamber.This issue was identified during setup and preparation prior to patient use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information was added to d9, h3 and h6.H10: the device was received for evaluation.Visual inspection was performed using the naked eye which observed a slightly tinge color and embedded particulate matters were on the chamber's wall surface.The slightly tinged color was determined to be due to the gamma sterilization process and does not impact the function of the set.Therefore, the slightly tinged color is not a nonconformance of the product.Further visual inspection of the sample observed embedded particulate matters (epm) on the drip chamber¿s wall surface.The epm was numerous and below size 0.02 giving a black-brownish appearance.A functional under water pressure test was performed on the sample and no leak was observed.The reported condition of contamination was verified.The cause of the condition is a manufacturing related issue and might be due to degradation of the resin during the molding process.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: CLEARLINK SECONDARY MEDICATION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12277323
• MDR Text Key: 265060370
• Report Number: 1416980-2021-04795
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412049069
• UDI-Public: (01)00085412049069
• Combination Product (y/n): Y
• PMA/PMN Number: K961225
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 09/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C7461
• Device Lot Number: SR21A07100
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/28/2021
• Date Manufacturer Received: 08/11/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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