MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC PI PICC 3L 6FRX55CM W/80CM HYDRO NIT SWG; CATHETER, INTRAVASCULAR, THER

Catalog Number	PR-35563-HPHNM
Medical Device Problem Codes	Crack (1135); Material Rupture (1546)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/14/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that: "extravasation noted to pt r) arm with ++ swelling to arm and r) hand.Tpn fluid noted under dressing.All infusions (heparin + tpn) stopped and picc removed.On removal of picc line, picc noted to have small hairline fracture distally on picc.Visible split to tubing just proximal to skin level.Tpn and heparin infusions were stopped until new picc line inserted.The device was removed in its entirety and picc was replaced." the returned device proved to be ruptured.Therapy was delayed but the patient was reported as fine post the incident.
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
It was reported that: "extravasation noted to pt r) arm with ++ swelling to arm and r) hand.Tpn fluid noted under dressing.All infusions (heparin + tpn) stopped and picc removed.On removal of picc line, picc noted to have small hairline fracture distally on picc.Visible split to tubing just proximal to skin level.Tpn and heparin infusions were stopped until new picc line inserted.The device was removed in its entirety and picc was replaced." the returned device proved to be ruptured.Therapy was delayed but the patient was reported as fine post the incident.
Additional Manufacturer Narrative
Qn# (b)(4).The customer returned one, 3-lumen picc for analysis.Signs of use in the form of biological material were observed.Visual analysis revealed that the catheter body contained a crease/stretch mark from the juncture hub to the 28/27cm marking.Microscopic examination confirmed the damage and revealed a hole along this crease.After flushing the catheter during functional testing, the crease appears to bulge slightly when flushing the proximal extension line.Similar, the catheter leaks from the hole when flushing the proximal extension line.The catheter body was cross-sectioned, and the further microscopic examination revealed that the outer wall of the proximal lumen was compromised.The catheter body length measured 22.125", which is within the specification limits of 21.921"-22.171" per the catheter product drawing.The catheter body outer diameter (in an area not affected by ballooning) measured 0.0795", which is within the specification limits of 0.0770"-0.0840" per the catheter extrusion product drawing.After cross-sectioning, the thickness of the medial lumen measured 0.00301", which is within the specification limits of 0.002"-0.004" per the catheter extrusion product drawing.The thickness of the proximal lumen (in a functional area) measured 0.00246", which is within the specification limits of 0.002"-0.004" per the catheter extrusion product drawing.A lab inventory syringe filled with water was attached to all three extension lines and flushed.When flushing the proximal line, the stretch mark appears to bulge slightly and water leaked from the hole.No leaks or anomalies when flushing the medial or distal extension line.Performed per ifu statement , "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".Members of r & d were contacted as part of this complaint.They confirmed that the reported defect appears consistent with over-pressurization of the catheter during use.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number taken from the sales history data of the customer.A finding was identified; however, it was determined that the finding was not relevant to this complaint issue.The ifu provided with the kit informs the user, "ensure catheter patency prior to use, including prior to pressure injection.Do not use syringes smaller than 10 ml to reduce risk of intraluminal leakage or catheter rupture.Power injector equipment may not prevent over pressurizing an occluded or partially occluded catheter".The ifu also states, "use only lumen(s) labeled 'pressure injectable' for pressure injection to reduce risk of catheter failure and/or patient complications.Refer to the arrow pressure injection information label for pressure injection information." the report of a ruptured catheter was confirmed through complaint investigation.Visual and functional analysis revealed that the proximal lumen was bulged along the catheter body.A rupture/hole was also observed along the bulging.Despite the damage, the catheter met all relevant dimensional requirements.Based on the customer report, the sample received, and the comments from r & d, unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

• Brand Name: PI PICC 3L 6FRX55CM W/80CM HYDRO NIT SWG
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• 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: 20143737
• Report Number: 9680794-2024-00855
• Device Sequence Number: 18207624
• Product Code: LJS
• UDI-Device Identifier: 00801902095657
• UDI-Public: (01)00801902095657(11)230921(17)250831(10)33F23H0476(21)
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K080604
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2024

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: 08/31/2025
• Device Catalogue Number: PR-35563-HPHNM
• Device Lot Number: 33F23H0476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/29/2024
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/14/2024
• Supplement Date Received by Manufacturer: 09/18/2024
• Initial Report FDA Received Date: 09/05/2024
• Supplement Report FDA Received Date: 09/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/21/2023
• 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: Unknown