MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 3-LUMEN 7 FR X 20 CM; CATHETER PERCUTANEOUS

Model Number	IPN918764
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	Respiratory Arrest (4461)
Date of Event	04/10/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, "the patient had been disintubated the day before.He was mobilized by the nurse to get to the chair.During mobilization, the blue and white fixation hubs pulled out of the extension lines.Both lines were quickly clamped.The patient soon presented respiratory distress (suspected gaseous pulmonary embolism).He was placed in the left lateral decubitus position.The patient went into respiratory arrest.The patient was resuscitated.The patient is now under observation in intensive care and his condition is stationary.At the time of the incident, the central line was being used to administer a 0.9 nacl solution.The central line has been replaced.Additional information received states "the patient is still in intensive care and is at the end of his life.The doctors are going to suggest to the family that care be discontinued.They consider that the event that occurred (suspected gas embolism, respiratory arrest and resuscitation) is not responsible for his critical condition, but that it undoubtedly accelerated things.They are aware that the event occurred because of "miss treating" of the patient, and that excessive tension on the lines (blue and white) is responsible for their tearing.".
Additional Manufacturer Narrative
(b)(4).
Additional Manufacturer Narrative
(b)(4) the customer returned one 3-lumen catheter for analysis.Signs of use in the form of biological material, were observed on the catheter body and within the extension lines.Visual analysis of the proximal and medial extension line revealed that their respective luer hubs had separated and were not returned.Microscopic analysis revealed evidence of compression lines adjacent to the points of separations of the extension lines.These compression lines could correlate to where the distal end of the luer hub sits on the extension line indicating the extension line material that is recessed within the luer hub was present.No visual damage was observed to the distal extension line.Visual examination of the proximal and medial separated hubs to evaluate the nature of the break could not be performed, as they were not returned for evaluation.The total length of the proximal extension line from the juncture hub to the point of separation measured 136mm, which is longer than the reference specification of 135mm per catheter product drawing.The proximal extension line outer diameter measured 2.14mm, which is within the specification limits of 2.13mm - 2.21mm per the proximal extension line extrusion product drawing.The proximal extension line inner diameter measured 1.4224mm, which is within the specification limits of 1.42mm - 1.50mm per proximal extension line extrusion product drawing.The total length of the medial extension line from the juncture hub to the point of separation measured 114mm, which is longer than the reference specification of 110mm per catheter product drawing.The medial extension line outer diameter measured 2.15mm, which is within the specification limits of 2.13mm - 2.21mm per medial extension line extrusion product drawing.The medial extension line inner diameter measured 1.4478mm, which is within the specification limits of 1.42mm - 1.50mm per medial extension line extrusion product drawing.Dimensional inspection of the separated luer hubs could not be performed as they were not returned for analysis.A manual tug test confirmed that the distal extension line was secure to its luer hubs.A device history record review was performed and no relevant findings were identified.The instructions for use (ifu) provided with this kit warns the user, "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." the report of an extension line/luer hub separation was confirmed through complaint investigation of the returned sample.Visual analysis revealed the proximal and medial extension lines had separated from their luer hubs; however, the luer hubs were not returned.The separation point on the extension lines suggest that the extension line material that is recessed within the luer hub was present, however, the nature of the break could not be confirmed without the separated hub returned.The customer report stated, "during mobilization, the blue and white fixation hubs pulled out of the extension lines" which suggests the damage occurred while the patient was being moved.A device history record review was performed based and no relevant findings were identified.Based on the sample received and without the luer hubs returned, the root cause cannot be determined.Teleflex will continue to monitor and trend complaints of this nature.
Event or Problem Description
It was reported "the patient had been disintubated the day before.He was mobilized by the nurse to get to the chair.During mobilization, the blue and white fixation hubs pulled out of the extension lines.Both lines were quickly clamped.The patient soon presented respiratory distress (suspected gaseous pulmonary embolism).He was placed in the left lateral decubitus position.The patient went into respiratory arrest.The patient was resuscitated.The patient is now under observation in intensive care and his condition is stationary.At the time of the incident, the central line was being used to administer a 0.9 nacl solution.The central line has been replaced.Additional information received states "the patient is still in intensive care and is at the end of his life.The doctors are going to suggest to the family that care be discontinued.They consider that the event that occurred (suspected gas embolism, respiratory arrest and resuscitation) is not responsible for his critical condition, but that it undoubtedly accelerated things.They are aware that the event occurred because of "miss treating" of the patient, and that excessive tension on the lines (blue and white) is responsible for their tearing.".

• Brand Name: ARROW CVC SET: 3-LUMEN 7 FR X 20 CM
• Common Device Name: CATHETER PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL CR, A.S.; jamska 2359/47; zdar nad sazavou 591 0 1; EZ 591 01
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21967895
• Report Number: 3006425876-2025-00429
• Device Sequence Number: 20865878
• Product Code: DQY
• UDI-Device Identifier: 10801902105339
• UDI-Public: (01)10801902105339(11)240711(17)281130(10)71F24F0545(21)
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/14/2025

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?: Yes
• Operator of Device: Health Professional
• Device Model Number: IPN918764
• Device Catalogue Number: CV-15703
• Device Lot Number: 71F24F0545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/02/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/14/2025
• Supplement Date Received by Manufacturer: 05/22/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/11/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Male