MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC 2-L: 5FR X 55CM W/ 130CM HYDRO N; CATHETPATIENTER, INTRAVASCULAR, THER

Catalog Number PR-35552-HPHNL

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Erythema (1840); Pain (1994); Sepsis (2067)

Event Date 10/25/2022

Event Type  malfunction  

Event Description

The complaint is reported as: a patient with a double lumen picc was unwell at home.The picc site was accessed/documented as clean/dry/not red and no pain when used.Patient became increasingly unwell at home with tachycardia, pain, oedema, generally feeling unwell.Patient transferred to hospital.Ecg and obs taken but picc not assessed/accessed and no medical review at this time.Patient went for an urgent ctpa to rule out a pulmonary embolism.Picc connected to pressure injector but no assessment undertaken by rn involved (didn't take down dressing so not sure what site looked like) flushed device pre and post (no issues) and ct competed without any immediate issues.Transferred to unit and picc assessment then undertaken and erythema noted at insertion site and complained of site/chest pain when flushed.Patient meeting sepsis pathway criteria so picc not used.Peripheral cultures taken and then picc removed.It was noted picc intact on examination.No fracture/damage was documented in the patient's notes.Device was thrown away.Blood cultures and insertion site swab and tip sent for cultures and all negative.Picc was insitu for 15 days.It was reported the user facility was unsure if the patient was septic or had sirs.It was reported the medical intervention was to treat the patient's presenting symptoms and start the sepsis pathway although there was no confirmed central line associated infection.It was presumed the picc was the source of the patient's infection.The patient's current condition was reported as "ok, having treatment with a new line i believe".

Manufacturer Narrative

Qn#(b)(4).

Manufacturer Narrative

(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 based on sales history, and one relevant findings was identified.A non-conformance was initiated for lot 13c22e1155 in regards to failure due to accumulation of tolerances.Without the sample returned, it cannot be confirmed if the failure mode of this complaint is the same as the non-conformance 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 Description

The complaint is reported as: a patient with a double lumen picc was unwell at home.The picc site was accessed/documented as clean/dry/not red and no pain when used.Patient became increasingly unwell at home with tachycardia, pain, oedema, generally feeling unwell.Patient transferred to hospital.Ecg and obs taken but picc not assessed/accessed and no medical review at this time.Patient went for an urgent ctpa to rule out a pulmonary embolism.Picc connected to pressure injector but no assessment undertaken by rn involved (didn't take down dressing so not sure what site looked like) flushed device pre and post (no issues) and ct competed without any immediate issues.Transferred to unit and picc assessment then undertaken and erythema noted at insertion site and complained of site/chest pain when flushed.Patient meeting sepsis pathway criteria so picc not used.Peripheral cultures taken and then picc removed.It was noted picc intact on examination.No fracture/damage was documented in the patient's notes.Device was thrown away.Blood cultures and insertion site swab and tip sent for cultures and all negative.Picc was insitu for 15 days.It was reported the user facility was unsure if the patient was septic or had sirs.It was reported the medical intervention was to treat the patient's presenting symptoms and start the sepsis pathway although there was no confirmed central line associated infection.It was presumed the picc was the source of the patient's infection.The patient's current condition was reported as "ok, having treatment with a new line i believe".

• Brand Name: ARROW PI PICC 2-L: 5FR X 55CM W/ 130CM HYDRO N
• Type of Device: CATHETPATIENTER, 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: 15814963
• MDR Text Key: 307806757
• Report Number: 9680794-2022-00721
• Device Sequence Number: 1
• Product Code: LJS
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K113277
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,User Facility,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/25/2022

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?: No
• Device Catalogue Number: PR-35552-HPHNL
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/25/2022
• Initial Date FDA Received: 11/17/2022
• Supplement Dates Manufacturer Received: 12/13/2022
• Supplement Dates FDA Received: 12/14/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Hospitalization; Required Intervention