MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI; CATHETER INTRAVASCULAR THERAPE

Catalog Number PR-35052-HPHNM

Device Problem Material Split, Cut or Torn (4008)

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

Event Date 09/27/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event Description

It was reported on 27sept2022 that: "the picc was inserted in icu (by icu doctor) on (b)(6) 2022.When the patient improved, he was transferred back on a ward on (b)(6) 2022.At some point the pink lumen became blocked, so it was clamped and not used.It was noticed some form of damage under the slide clamp on (b)(6) 2022.She undid the clamp, and noticed the catheter was severed.Her immediate action was to slide the clamp upwards on the catheter and secure it to prevent air entry to patient.Medical team was informed and the picc was removed." the picc device was removed in its entirety and replaced.Therapy was not delayed or interrupted.There were no reported harm or co mplications to the patient.The current patient's condition was reported as fine.Additional information on 13oct2022: it was reported, "looks like it was broken (torn) under the clamp.Still connected in one piece.".

Event Description

It was reported on 27sept2022 that: "the picc was inserted in icu (by icu doctor) on 11aug2022.When the patient improved, he was transferred back on a ward on 12aug2022.At some point the pink lumen became blocked, so it was clamped and not used.It was noticed some form of damage under the slide clamp on 27sept2022.She undid the clamp, and noticed the catheter was severed.Her immediate action was to slide the clamp upwards on the catheter and secure it to prevent air entry to patient.Medical team was informed and the picc was removed." the picc device was removed in its entirety and replaced.Therapy was not delayed or interrupted.There were no reported harm or complications to the patient.The current patient's condition was reported as fine.Additional information on 13oct2022: it was reported, "looks like it was broken (torn) under the clamp.Still connected in one piece.".

Manufacturer Narrative

Qn # (b)(4).The customer returned one 2-l catheter for analysis.Definite signs of use in the form of biological material was found within the extension lines.Visual analysis revealed a hole in the middle of the distal extension line.The edges of the hole appear rough and jagged.No obvious defects were noted on the slide clamp of the distal extension line.The catheter body was not returned for analysis, so it is being assumed that the customer intentionally severed it.The outer diameter of the distal extension line measured 0.0968", which is within the specification limits of 0.093" - 0.097" per the distal extension line extrusion graphic.The inner diameter of the distal extension line measured 0.058", which is within the specification limits of 0.055" - 0.059" per the distal extension line extrusion graphic.This indicates that the wall thickness is as expected.The catheter was functionally tested per the instructions for use (ifu) provided with this kit, which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." both extension lines were flushed and water was observed to be leaking from the distal extension line.The proximal extension line flushed as intended.A manual tug test confirmed that both extension lines were secure within their respective hubs.R & d engineers were contacted regarding this failure mode.They stated that the appearance and severity of the hole is consistent with damage of continuously clamping the extension line in the same location with a slide clamp or other clamping device.A device history record review was performed based on sales history, and a potentially relevant finding was identified.A non-conformance was initiated for batch 13p21f0249 regarding resin being out of specification.Further analysis of the returned sample revealed that the finding is not relevant to the investigation.The ifu provided with this kit informs the user, "warning: open clamp prior to infusion through lumen to reduce risk of damage to extension line from excessive pressure.Warning: do not clamp extension line in close proximity of the extension line hub to reduce the risk of component damage".The customer report of an extension line leak could be confirmed based on complaint investigation of the returned sample.Visual and functional analysis revealed a hole in the distal extension line.The catheter passed all relevant dimensional analysis.R & d was contacted regarding the failure mode and they stated that such a damage can occur from continuously clamping the same location on the extension line.Based on the customer report, comments from r & d, and the sample received, it was determined that unintentional use error likely caused or contributed to this event.Teleflex will continue to monitor and trend for complaints of this nature.

• Brand Name: ARROW PI PICC: 2-L 5FR X 50CM W/ 80CM HYDRO NI
• 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: 15693782
• MDR Text Key: 307088653
• Report Number: 9680794-2022-00675
• 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: 10/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/28/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Catalogue Number: PR-35052-HPHNM
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/27/2022
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/18/2022
• Was Device Evaluated by Manufacturer?: Yes
• 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