MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS; STOPCOCK, I.V. SET

Catalog Number 2C6255

Device Problems Disconnection (1171); Failure to Disconnect (2541)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

The events occurred on unspecified dates prior to and around (b)(6) 2019.(b)(4).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that an unspecified quantity of clearlink continu-flo stopcock/solution sets were breaking.It was further specified there was difficulty with the blue caps; when attempting to pull off the caps, the tubing broke (tubing detached from the luer).This was identified during preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

One (1) device was received for evaluation.A visual inspection was performed, and it was noted that the tubing was separated from the male luer.An excess of solvent was also observed in the tubing.The tubing was inserted into the male luer according to specification.Dimensional testing was also performed and the tubing and male luer dimensions were according to specification.The reported condition was verified.The cause of the reported condition was due to an excess of solvent on the tubing applied during the automated solvent application 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 CONTINU-FLO STOPCOCK AND I.V. SOLUTION ADMINISTRATION SETS
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - CARTAGO; cartago
• MDR Report Key: 8769113
• MDR Text Key: 150317893
• Report Number: 1416980-2019-03658
• Device Sequence Number: 1
• Product Code: FMG
• UDI-Device Identifier: 00085412046310
• UDI-Public: (01)00085412046310
• Combination Product (y/n): N
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/08/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C6255
• Device Lot Number: R18L01061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2019
• Date Manufacturer Received: 08/01/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1