MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION DUO-VENT CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number 2C8419

Device Problem Break (1069)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

This event occurred during the unspecified date of (b)(6) 2020.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that when twisting, the luer lock of 5 clearlink system solution sets broke.This was identified during preparation.There was no patient involvement.No additional information is available.

Manufacturer Narrative

H10: one (1) actual sample was received for evaluation.The other four (4) devices were not received and therefore, could not be evaluated.The sample was received out of the pouch fully primed.No visual residue of propofol was noted on the luer collar.It was observed that the male luer collar was broken, however, it was reported that the nurses use chlorhexidine to clean the luer lock prior to connection.The disinfectant chlorhexidine can cause etching/cracking of the luer lock collar material.Therefore, the reported condition was not verified as a nonconforming product because the cause was determined to be due to the customer¿s disinfecting method.Due to the nature of the returned sample, no additional testing could be performed.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.

Manufacturer Narrative

Further clarification was received from the customer stating that they are ¿not swabbing the male luer¿ (as a disinfecting method).The customer is priming the set with propofol while keeping the blue cap on the end of the set.The priming may take place quite some time prior to use, however, exact amount of time is unknown.Remove the statement that ¿the cause of the condition was due to the customer¿s disinfecting method¿ (reported on the initial).Update to: the cause of the condition could not be determined; however, based on the sample evaluation, the cause of the condition could have been due to the customer¿s priming method.If the propofol solution contains lipids, it may have a negative effect on polycarbonate.If the user is priming the sets with propofol and the blue tip protector is attached to the male luer, the propofol can back wash up into the male luer collar and have a negative effect.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: DUO-VENT CLEARLINK LUER ACTIVATED VALVE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• MDR Report Key: 11088453
• MDR Text Key: 224759757
• Report Number: 1416980-2020-08139
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00085412048956
• UDI-Public: (01)00085412048956
• Combination Product (y/n): Y
• PMA/PMN Number: K112893
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 05/18/2021

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: 2C8419
• Device Lot Number: SR20B19083
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/13/2021
• Initial Date Manufacturer Received: 12/03/2020
• Initial Date FDA Received: 12/29/2020
• Supplement Dates Manufacturer Received: 01/19/2021; 05/13/2021
• Supplement Dates FDA Received: 02/05/2021; 05/18/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1