MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW CVC SET: 4-LUMEN 8.5FR X 16CM; CATHETER, PERCUTANEOUS

Model Number	IPN030865
Medical Device Problem Codes	Disconnection (1171); Material Separation (1562)
Health Effect - Clinical Codes	High Blood Pressure/ Hypertension (1908); Anxiety (2328); Low Oxygen Saturation (2477)
Date of Event	09/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported "on the day of the incident, the central venous catheter's distal line extender, which had been inserted on (b)(6) 2024 at around 6pm, was found disconnected.The connector connected to the extension line was found broken on the floor.The team observed that there was no blood on the floor or sheets and performed an emergency purge of 10 ml of air and clamped.Due to moderate symptoms, there was a suspicion of gas embolism.Desaturation 86% and systolic arterial hypertension 220 mm hg.Treatment with hyperbaric oxygen therapy.No further consequence after the incident.The patient may have stayed about 30 minutes with the extension line disconnected.The patient became anxious following this episode.The central venous line is still in place, the extension line was discarded." the patient returned to normal hemodynamics.The patient's current condition is reported as "fine".
Additional Manufacturer Narrative
Qn #(b)(4).Complaint verification testing could not be performed as it was reported that the sample is not available for return.A device history record review was performed and no relevant findings were identified.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
It was reported "on the day of the incident, the central venous catheter's distal line extender, which had been inserted on (b)(6) 2024 at around 6pm, was found disconnected.The connector connected to the extension line was found broken on the floor.The team observed that there was no blood on the floor or sheets and performed an emergency purge of 10 ml of air and clamped.Due to moderate symptoms, there was a suspicion of gas embolism.Desaturation 86% and systolic arterial hypertension 220 mm hg.Treatment with hyperbaric oxygen therapy.No further consequence after the incident.The patient may have stayed about 30 minutes with the extension line disconnected.The patient became anxious following this episode.The central venous line is still in place, the extension line was discarded." the patient returned to normal hemodynamics.The patient's current condition is reported as "fine".

• Brand Name: ARROW CVC SET: 4-LUMEN 8.5FR X 16CM
• 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: 20522152
• Report Number: 3006425876-2024-01024
• Device Sequence Number: 20813333
• Product Code: DQY
• UDI-Device Identifier: 10801902029239
• UDI-Public: (01)10801902029239(11)200417(17)250131(10)71F20D1159(21)
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 09/30/2024

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 Expiration Date: 01/31/2025
• Device Model Number: IPN030865
• Device Catalogue Number: CV-12854
• Device Lot Number: 71F20D1159
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2024
• Supplement Date Received by Manufacturer: 11/19/2024
• Initial Report FDA Received Date: 10/24/2024
• Supplement Report FDA Received Date: 11/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2020
• 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: NONE REPORTED.; NONE REPORTED.
• Patient Age: 75 YR
• Patient Sex: Female