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

Catalog Number	2H8537
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/18/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a clearlink continu-flo solution set was cut in two at the slide clamp.This issue was identified after use when the nurse opened the slide clamp.The patient was not connected to the set.No additional information is available.
Additional Manufacturer Narrative
Correction to d4: expiration date: incorrect expiration date listed.Remove expiration date as it is not applicable for this device.H10: the device was received for evaluation.A visual inspection was performed using the naked eye which revealed the tubing was cut by the slide clamp.Due to the nature of the reported problem no additional testing could be performed.The reported condition was verified.The cause of the condition could not be determined.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 CONTINU-FLO SOLUTION SET
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 9459963
• Report Number: 1416980-2019-06856
• Device Sequence Number: 3091507
• Product Code: FPA
• UDI-Device Identifier: 00085412080901
• UDI-Public: (01)00085412080901
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K961225
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2020

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
• Operator of Device: Health Professional
• Device Expiration Date: 05/24/2024
• Device Catalogue Number: 2H8537
• Device Lot Number: R19E24073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/05/2019
• Initial Date Received by Manufacturer: 11/20/2019
• Supplement Date Received by Manufacturer: 01/08/2020
• Initial Report FDA Received Date: 12/12/2019
• Supplement Report FDA Received Date: 01/17/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1