MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM); CATHETER, INTRAVASCULAR, THER

Model Number	IPN033364
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/29/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn#: (b)(4).
Event or Problem Description
The nurse found the catheter leaking at the juncture hub from the proximal port.Catheter had been inserted on (b)(6) 2021.It was r eported the device was removed and the doctor changed the catheter.There was a delay in therapy without harm to the patient.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4), the customer provided three photos and one video.The reported complaint of a juncture hub leak was able to be confirmed from the first photo and the video provided.The first photo showed evidence of leakage in the form of liquid droplets at the juncture hub.The second and third photos showed the lidstock of the finished kit.The finished good part number and lot number were able to be confirmed from the second and third photos.Visual analysis of the customer video revealed that the juncture hub leaked when pressurizing the proximal extension line.The customer also returned one picc catheter and a lidstock for analysis.Signs of use in the form of biological material was observed inside the distal extension line.Visual analysis of the returned sample revealed that the distal end of the juncture hub was defective.The appearance of this defect appeared consistent with a molding defect.This subsequently created a hole leading into the proximal lumen.The ifu provided with this kit states: "2.Attach syringe to sidearm and flush distal lumen with sterile saline solution.Leave syringe in place.3.Flush remaining lumen(s) with sterile saline.Clamp or attach injection site cap(s) to extension line(s) to contain saline within lumen." a lab inventory syringe filled with water was used to test for leaks on the returned catheter.When the proximal lumen was injected, water was observed leaking out of the hole in the juncture hub.No leaks were observed when injecting the distal extension line.A device history record review was performed with a relevant finding.A non-conformance was initiated for catheter leaks.This finding could be linked to the failure mode observed in this complaint.The customer report of a leaking juncture hub was confirmed through complaint investigation.Visual and functional analysis revealed that the catheter leaked out of a small hole in the juncture hub when injecting water through the proximal lumen.A device history record review was performed, and a relevant finding was identified.A non-conformance was initiated for catheter leaks.This finding could be linked to the failure mode observed in this complaint.Based on the customer report and the sample received, manufacturing caused or contributed to this event.A non-conformance request was initiated to further investigate this complaint issue.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The nurse found the catheter leaking at the juncture hub from the proximal port.Catheter had been inserted on (b)(6) 2021.It was reported the device was removed and the doctor changed the catheter.There was a delay in therapy without harm to the patient.The patient's condition is reported as fine.

• Brand Name: ARROW PICC SET: 2-LUMEN 5 FR X 19-1/2" (50 CM)
• Common Device Name: CATHETER, INTRAVASCULAR, THER
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11993943
• Report Number: 9680794-2021-00297
• Device Sequence Number: 3214957
• Product Code: LJS
• UDI-Device Identifier: 50801902095393
• UDI-Public: 50801902095393
• Combination Product (Y/N): N
• Initial Reporter Country: TH
• PMA/510(K) Number: K073451
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,distri
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 05/29/2021

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: 12/31/2022
• Device Model Number: IPN033364
• Device Catalogue Number: PR-05052-LW
• Device Lot Number: 14F21A0015
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/14/2021
• Initial Date Received by Manufacturer: 05/29/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 06/14/2021
• Supplement Report FDA Received Date: 07/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: NONE REPORTED.; NONE REPORTED.; NONE REPORTED.