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

Catalog Number 2C8541

Device Problem Component Missing (2306)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of clearlink system continu-flo solution sets were missing the protective cap on the spike.This was noted before product use.There was no patient involvement.No additional information is available.

Manufacturer Narrative

Additional information : the device was received for evaluation.A visual inspection was performed which revealed that the tip protector was missing and not found on the drip chamber.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 DUO-VENT CONTINU-FLO SOLUTION SET
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• Manufacturer (Section G): BAXTER HEALTHCARE - CARTAGO; see h10; h10; cartago 30106 ; CS 30106
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 8668214
• MDR Text Key: 146974582
• Report Number: 1416980-2019-03063
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412071107
• UDI-Public: (01)00085412071107
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 2C8541
• Device Lot Number: R18L10153
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/03/2019
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/11/2018
• 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