MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW EXT DWELL CATH DEVICE 20GAX8CM; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037862
Medical Device Problem Code	Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	03/09/2022
Type of Reportable Event	Serious Injury
Event or Problem Description
Complaint found in maude database reports: "picc line placement attempt resulted in catheter that would not thread and upon removal noted the tip of catheter looked torn.Us and doppler confirmed catheter fragment in cephalic vein.Linear echogenic structure in the left central upper arm in the cephalic vein is consistent with a small piece of retained catheter fragment.Vascular consulted.".
Additional Manufacturer Narrative
(b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).The report number is mw5108215.
Additional Manufacturer Narrative
(b)(4).The mdr report key is (b)(4).The mdr text key is (b)(4).The report number is mw5108215.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 and no relevant findings were 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 or Problem Description
Complaint found in maude database reports: "picc line placement attempt resulted in catheter that would not thread and upon removal noted the tip of catheter looked torn.Us and doppler confirmed catheter fragment in cephalic vein.Linear echogenic structure in the left central upper arm in the cephalic vein is consistent with a small piece of retained catheter fragment.Vascular consulted.".

• Brand Name: ARROW EXT DWELL CATH DEVICE 20GAX8CM
• Common Device Name: 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: 14312592
• Report Number: 9680794-2022-00272
• Device Sequence Number: 12012006
• Product Code: FOZ
• UDI-Device Identifier: 10801902132960
• UDI-Public: 10801902132960
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: K151513
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2022

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?: Yes
• Device Expiration Date: 11/30/2023
• Device Model Number: IPN037862
• Device Catalogue Number: EDC-00820
• Device Lot Number: 14F21M0014
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/13/2022
• Supplement Date Received by Manufacturer: 05/31/2022
• Initial Report FDA Received Date: 05/06/2022
• Supplement Report FDA Received Date: 06/01/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/13/2021
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown