MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW AM PICC SET: 1-L 4.5FR X 55CM 130CM HYDR; CATHETER INTRAVASCULAR THERAPE

Catalog Number PR-45541-HPHNL

Device Problem Stretched (1601)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/25/2022

Event Type  malfunction  

Event Description

The complaint is reported as: upon removal of picc line from patient, noted that the extension piece close to the hub was flattened and not returning to original round state.Patient states that it was like that for 2 days and still able to flush line.No patient harm or medical intervention was reported.The patient's condition was reported as fine.

Manufacturer Narrative

(b)(4).

Manufacturer Narrative

(b)(4).The customer returned one, single-lumen picc for analysis.Signs of use in the form of biological material was observed inside the extension line.Visual analysis of the distal extension line confirmed the line was stretched.There was a clear transition point in the extension line where the line began to stretch/balloon directly adjacent to the luer hub.The damage is consistent with the line being over-pressurized.After failing functional analysis (see below), a slight blockage was encountered due to a build-up of congealed biological material.This blockage likely contributed to the extension line ballooning.The catheter body length from the juncture hub to the distal tip measured 22 1/8", which is within the specification limits of 21 5/8"-22 1/8" per the coated catheter product drawing.The distal extension line outer diameter (in an area not affected by ballooning) measured.0945", which is within the specification limits of.0930"-.0970" per the distal extension line extrusion product drawings.To measure the inner diameter, the distal extension line was intentionally severed just distal to the ballooning.The distal extension line inner diameter measured.058", which is within the specification limits of.055".059" per the distal extension line extrusion product drawings.A lab inventory syringe filled with water was attached to the distal extension line and flushed.A blockage was encountered with prevented the water from flushing.A long pin gage was inserted through the catheter body.Large quantities of congealed biological material were observed exiting the distal tip.This build-up of biomaterial likely contributed to the blockage and subsequent ballooning.After the blockage was cleared, the line appeared to flush as intended.Performed per ifu statement, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)".A manual tug test confirmed the distal line was secure to the luer hub.A device history record review was performed, and no relevant findings were identified.The ifu provided with the kit informs the user, "open clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure".The ifu also states, "ensure patency of each lumen of catheter prior to pressure injection to minimize the risk of catheter failure and/or patient complications".The ifu also states, "do not exceed maximum pressure of 300 psi (2068.4 kpa) on power injector equipment to reduce risk of catheter failure and/or tip displacement.Do not exceed ten (10) injections or catheter's maximum recommended flow rate located on product labeling and catheter luer hub to minimize the risk of catheter failure and/or tip displacement".The report of a ballooning/stretched extension line was confirmed through complaint investigation of the returned sample.Visual analysis revealed that the distal extension line was severely ballooned/stretched.Significant quantities of congealed biological material were also observed occluding the catheter body.This blockage in combination with over-pressurizing likely contributed to the ballooning of the extension line.Aside from the damage, the catheter met all relevant dimensional and functional requirements, and a device history report review did not reveal any relevant findings.Based on the customer report and the sample received , unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for reports of this nature.

Event Description

The complaint is reported as: "upon removal of picc line from patient, noted that the extension piece close to the hub was flattened and not returning to original round state.Patient states that it was like that for 2 days and still able to flush line." no patient harm or medical intervention was reported.The patient's condition was reported as fine.

• Brand Name: ARROW AM PICC SET: 1-L 4.5FR X 55CM 130CM HYDR
• Type of Device: CATHETER INTRAVASCULAR THERAPE
• 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: 15759565
• MDR Text Key: 303626792
• Report Number: 9680794-2022-00692
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K112896
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: PR-45541-HPHNL
• Device Lot Number: 13F22A0557
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/02/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/30/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/22/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: NOT REPORTED.; NOT REPORTED.