MAUDE Adverse Event Report: MEDSOURCE LABS, LLC PREMIERPRO; CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Model Number	31TB20100
Health Effect - Clinical Codes	Extravasation (1842); Infiltration into Tissue (1931)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Multiple issues with the truesafe comfort blood control iv catheter.Reports contain all gauge catheters.Various complaints: 1.Catheter would not advance.2.Catheter retracted early causing the vein to blow 3.Infiltrations.4.Catheter does not connect to tubing connection well.5.During pressure injection ct; the catheter and connection disconnect.6.Iv need would not retract after starting iv.Had to pull the entire device out of the patient's arm to retract the needle.
Additional Manufacturer Narrative
Three attempts were made to contact the initial reporter.No acknowlegement or response was received.No product was available to be returned for evaluation and investigation.The lot number information that was provided was "multiple".Due to not having specific lot information, an investigation was performed on retention samples of 31tb20100, lot #: 40065/0043 manufacturing date: 2024-04-30, expiration date: 2029-03-31.The batch manufacturing records (bmr) for the reported batch were reviewed.No non-conformities related to the complaint were observed.Reports were verified for any supplier or raw material changes.No changes were incorporated in the process or material.The following tests were performed on the control samples to investigate the reported complaint: 1.Visual inspection 2.6% taper test 3.Gripping of needle with catheter 4.Bevels heal distance 5.Penetration test 6.Pull test of the catheter 7.Leakage test additionally, power injection testing has been performed for this device and no disconnection was observed in the product up to 550psi.Based on the root cause analysis and the results obtained from the tests carried out on control samples of 31tb20100, it is concluded that the product does not contain a manufacturing defect.The problem may be related to the user, as the product meets the specified requirements in the testing.The reported complaint may be related to user error with the following possibilities: device may not have been used as intended by the manufacturer.Catheter may have been damaged or deformed due to multiple insertion attempts by the end user.Wrong selection of anatomical location of cannulation site.Mating part of the other device may not be proper and in compliance to iso 80369-7.
Event or Problem Description
Multiple issues with the truesafe comfort blood control iv catheter.Reports contain all gauge catheters.Various complaints: 1.Catheter would not advance 2.Catheter retracted early causing the vein to blow 3.Infiltrations 4.Catheter does not connect to tubing connection well 5.During pressure injection ct; the catheter and connection disconnect.6.Iv need would not retract after starting iv.Had to pull the entire device out of the patient's arm to retract the needle.

• Brand Name: PREMIERPRO
• Common Device Name: CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): MEDSOURCE LABS, LLC; 8600 shelby ct.; suite 100; chanhassen MN 55317
• MDR Report Key: 19613246
• Report Number: 19613246
• Device Sequence Number: 6974745
• Product Code: FOZ
• UDI-Device Identifier: 00811220034795
• UDI-Public: (01)00811220034795
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/04/2024
• Report Date (Section F): 06/04/2024

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 Model Number: 31TB20100
• Device Catalogue Number: 31TB20100
• Device Lot Number: MULTIPLE
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report to Manufacturer: 06/26/2024
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/26/2024
• Supplement Report FDA Received Date: 12/04/2024
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Patient Sex: Unknown
• Date Report Sent to FDA: 06/04/2024