MAUDE Adverse Event Report: MEDICAL COMPONENTS, INC. 9.5F X 90CM DBL LMN CVC CATH; LT SILICONE CVC

Model Number	MR28010921
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/07/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Red lumen used for bloodwork.After bloodwork completed, writer flushed line w/ normal saline syringes & the line appeared to explode, spraying saline out.Clarification provided indicates the luer came out of the arterial extension tubing.Writer immediately clamped & inspected line - no hole/perforation; part of line attached to needleless connector had become disconnected & was still attached to flush.Part in question appears to be intact.Patient fine, writer explained what happened, charge nurse notified.Red lumen clamped w/ device clamp & kelly clamp.
Additional Manufacturer Narrative
We are currently waiting for the device to be returned for evaluation.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.
Additional Manufacturer Narrative
The 9.5f cvc was returned for evaluation with the luer and end cap from the pink extension separated from the catheter.The luer stem was reviewed under magnification, as well as the luer sleeve inner diameter.No obvious defects or marks from instruments such as hemostats were noted.The intact luer on the blue extension was pulled but could not be dislodged from the luer sleeve.A supplier corrective action request was issued to the contract manufacturer for this event.The contract manufacturer's investigation revealed all relative dimensions were taken on the returned device and found to be within specification.Without a lot number a review of the manufacture records was not possible.Testing was conducted in an attempt to replicate the issue.Five different test with the luer intentionally not fully inserted into the extension tubing with various gaps were conducted.In all cases, the amount of force required to dislodge the luer from the extension was above the minimum force allowed.The failure mode could not be replicated.The circumstances that may have caused this event cannot be determined.Based on historic data this is not a systemic issue and is considered an isolated incident.This type of event will be trended through the complaint handling process.The instructions for use (ifu) contains the following precautions: *use only luer lock (threaded) connections with this catheter (including syringes, iv tubing, and end caps).*repeated overtightening of syringes and caps will reduce connector life and could lead to potential connector failure.*a 10cc syringe or larger should be used.The smaller the volume of the syringe, the higher the pressure that can be generated.Catheter rupture with possible embolization may occur.Device was used for treatment, not diagnosis.If information is obtained that was not available for the initial medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: 9.5F X 90CM DBL LMN CVC CATH
• Common Device Name: LT SILICONE CVC
• Manufacturer (Section D): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer (Section G): MEDICAL COMPONENTS, INC.; 1499 delp drive; harleysville PA 19438
• Manufacturer Contact: lynn winkler ; 1499 delp drive; harleysville, PA 19438 ; 2152564201
• MDR Report Key: 17631497
• Report Number: 2518902-2023-00057
• Device Sequence Number: 18053560
• Product Code: LJS
• UDI-Device Identifier: 00884908084290
• UDI-Public: 00884908084290
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K102966
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 11/08/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Other
• Device Model Number: MR28010921
• Device Catalogue Number: MR28010921
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/23/2023
• Supplement Date Received by Manufacturer: 08/23/2023
• Initial Report FDA Received Date: 08/28/2023
• Supplement Report FDA Received Date: 11/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown