MAUDE Adverse Event Report: CLEARLINK LUER ACTIVATED VALVE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	2N8378
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was a disconnection between a clearlink system non-dehp catheter extension set and a non-baxter syringe.It was further stated the set was sterile welded to a product transfer bag in order to connect the non-baxter syringe and perform sampling using the luer activated valve.After connecting the non-baxter syringe to the luer activated valve and during sampling, the connection between the luer activated valve (male luer lock) and the tubing (female luer lock) suddenly disconnected which resulted in a leak.The issue was identified during set up and preparation.It was stated that instruction of use were properly followed in terms of proper aseptic technique and cautions.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information was added to h3, h4 and h6.H10: the actual device was not available; however, a photograph of the sample and a companion sample were received for evaluation.A visual inspection was performed to the photograph using the naked eye which revealed that the clearlink system, non-dehp catheter ext.Set was without the luer activated valve for iv (intravenous) access.Due to the nature of the sample no further testing could be performed.The reported condition was verified through the evaluation of the photograph.The cause of the condition could not be determined.A visual inspection was performed on the companion sample, no obvious defects were observed.Functional tests were performed which checked the in-line luer connection and also checked accessing the luer activated valve by firmly pushing the male luer of a connecting device directly against the luer activated surface and rotating until the connection was secure.The set was primed and clear passage and pressures tests were performed with no issues noted.The reported condition was not verified during evaluation of the companion sample.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.
Additional Manufacturer Narrative
Correction e1: update initial reporter address, city, postal code, phone no.(omitted on initial report).E1: initial reporter address: (b)(6).E1: initial reporter city: (b)(6).E1: initial reporter postal code: (b)(6).E1: initial reporter phone no.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: CLEARLINK LUER ACTIVATED VALVE
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12259359
• Report Number: 1416980-2021-04694
• Device Sequence Number: 11680300
• Product Code: FPA
• UDI-Device Identifier: 00085412048918
• UDI-Public: (01)00085412048918
• Combination Product (Y/N): Y
• Initial Reporter Country: CA
• PMA/510(K) Number: K112893
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 11/01/2021

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
• Operator of Device: Health Professional
• Device Catalogue Number: 2N8378
• Device Lot Number: UR19E23018
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/07/2021
• Supplement Date Received by Manufacturer: 09/01/2021; 10/18/2021
• Initial Report FDA Received Date: 08/02/2021
• Supplement Report FDA Received Date: 09/03/2021; 11/01/2021
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 05/24/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1