MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS; CATHETER, INTRAVASCULAR, THERA

Catalog Number	ASK-45563-UWH1
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	Swelling/ Edema (4577)
Date of Event	01/27/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that a triple lumen picc line was placed, cut at 41 cm, and left 1 cm out.A dressing change was performed, at which time the picc was noted to be 1.5 cm out.At the time of removal, the picc remained 1.5 cm out.Upon removal, an obvious hole was noted in the line.After removal, all lumens were flushed, and it was determined that only the pink lumen was affected.Venous access team (vat) was consulted for vascular access assessment.The patient had undergone a ct scan, during which the power injector was attached to the pink lumen.When the ct technician tested the line with normal saline, the patient reported hearing a "plastic popping noise." the ct technician discontinued the infusion upon noticing upper arm swelling around the insertion site and completed the scan using the patient's peripheral iv (piv).The vat, along with the bedside nurse, assessed the picc line and noted old bloody drainage within the chg patch.The patient also exhibited bruising around the dressing, which appeared old and stable.The patient and bedside nurse reported that upper arm swelling was initially present upon returning from ct, but this was not appreciated at the time of vat assessment.Both the blue and white lumens were flushed and drew back without difficulty.However, upon attempting to flush the pink lumen, saline was observed under the dressing.The picc line was removed.The patient tolerated the removal well and had an existing piv for antibiotic administration.The team will reassess the need for central access.
Event or Problem Description
It was reported that a triple lumen picc line was placed, cut at 41 cm, and left 1 cm out.A dressing change was performed, at which time the picc was noted to be 1.5 cm out.At the time of removal, the picc remained 1.5 cm out.Upon removal, an obvious hole was noted in the line.After removal, all lumens were flushed, and it was determined that only the pink lumen was affected.Venous access team (vat) was consulted for vascular access assessment.The patient had undergone a ct scan, during which the power injector was attached to the pink lumen.When the ct technician tested the line with normal saline, the patient reported hearing a "plastic popping noise." the ct technician discontinued the infusion upon noticing upper arm swelling around the insertion site and completed the scan using the patient's peripheral iv (piv).The vat, along with the bedside nurse, assessed the picc line and noted old bloody drainage within the chg patch.The patient also exhibited bruising around the dressing, which appeared old and stable.The patient and bedside nurse reported that upper arm swelling was initially present upon returning from ct, but this was not appreciated at the time of vat assessment.Both the blue and white lumens were flushed and drew back without difficulty.However, upon attempting to flush the pink lumen, saline was observed under the dressing.The picc line was removed.The patient tolerated the removal well and had an existing piv for antibiotic administration.The team will reassess the need for central access.
Additional Manufacturer Narrative
Qn#(b)(4).The customer returned one, 3-lumen pressure injectable picc for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the catheter body was ruptured towards the juncture hub.Microscopic examination confirmed the damage and revealed that the appearance of the rupture is consistent with a pressure related break.Deformation or slight stretching of the catheter body was also noted directly adjacent to the tear, which, in combination with the catheter hole, is consistent with the appearance of over pressuring within the catheter.No damage or anomalies were observed with either of the extension lines.During functional testing, an occlusion of biological material was observed within the distal pink lumen.Microscopic analysis confirmed the biological material.The hole in the catheter body measured 20-26 mm from the juncture hub.The total length of the catheter body measured 42.7 cm, which is not within the specification limits of 54.85-57.76 cm per catheter product drawing.This matches the customer report that the picc was intentionally trimmed around 41 cm.The catheter outer diameter measured 0.082", which is within the specification limits of 0.078"-0.083" per catheter extrusion product drawing.The catheter was functionally tested per the instructions for use (ifu) provided with this kit which instructs the user, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." the catheter extension lines were individually flushed using a lab inventory syringe.The white and blue extension lines flushed as intended without leaks or blockages observed.The distal pink extension line was flushed, and a leak was observed from only the ruptured hole.Biological material was observed within the distal pink lumen of the catheter body which had formed an occlusion.An occlusion within the catheter body could contribute to overpressure within the lumen and an increased risk of catheter rupture.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "the maximum pressure of pressure injector equipment used with the pressure injectable picc may not exceed 300 psi (2068.4 kpa).The maximum pressure injection flow rate ranges from 4 ml/sec to 6 ml/sec.Refer to the product specific labeling for the maximum pressure injection flow rate for the specific lumen being used for pressure injection." the pressure injection info card states for a 6fr x 55cm, 3-lumen picc, the max indicated pressure injection flow rate for the pink extension line is 6 ml/sec.The blue and white extension lines are not intended to be used for pressure injections.The report of a ruptured catheter was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the catheter body was ruptured towards the juncture hub.The appearance of the hole is consistent with damage due to over pressurization within the catheter.During functional testing , an occlusion of biological material was observed within the distal pink lumen of the catheter body.An occlusion within the catheter body could contribute to overpressure within the lumen and an increased risk of catheter rupture.Based on the customer report and the sample received, unintentional use error (occlusion leading to over pressurization) caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: ARROW PI AGBA PICC KIT: 3L 6 FR X 55 CM W/VPS
• Common Device Name: CATHETER, INTRAVASCULAR, THERA
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL DE MEXICO S.A. DE C.V.; ave. washington 3701; colonia panamericana, chihuahua; chihuahua 31200 ; MX 31200
• Manufacturer Contact: katharine tarpley ; 3015 carrington mill blvd; morrisville, NC 27560
• MDR Report Key: 21365146
• Report Number: 9680794-2025-00139
• Device Sequence Number: 18246804
• Product Code: LJS
• UDI-Device Identifier: 10801902217223
• UDI-Public: (01)10801902217223(11)240801(17)250926(10)33F24H0022(21)
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K112896
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2025

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 Expiration Date: 09/26/2025
• Device Catalogue Number: ASK-45563-UWH1
• Device Lot Number: 33F24H0022
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/30/2025
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/27/2025
• Supplement Date Received by Manufacturer: 02/19/2025
• Initial Report FDA Received Date: 02/12/2025
• Supplement Report FDA Received Date: 02/25/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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: Female