MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC SET: 2-L 16 GA X 19-1/2" (50 CM); CATHETER INTRAVASCULAR THERAPE

Model Number	IPN914865
Medical Device Problem Code	Material Rupture (1546)
Health Effect - Clinical Code	Extravasation (1842)
Date of Event	11/23/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
The complaint is reported as: the catheter had a "rupture in the middle" and "fluid leaked into non-intravascular spaces causing phlebitis" in the patient's upper limb.The catheter was removed and replaced immediately.It was unknown if the patient received treatment for the "phlebitis".The patient's condition was reported as "in optimal health".
Additional 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 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
The complaint is reported as: the catheter had a "rupture in the middle" and "fluid leaked into non-intravascular spaces causing phlebitis" in the patient's upper limb.The catheter was removed and replaced immediately.It was unknown if the patient received treatment for the "phlebitis".The patient's condition was reported as "in optimal health".

• Brand Name: ARROW PICC SET: 2-L 16 GA X 19-1/2" (50 CM)
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11236396
• Report Number: 9680794-2021-00017
• Device Sequence Number: 14488427
• Product Code: LJS
• UDI-Device Identifier: 10801902158403
• UDI-Public: 10801902158403
• Combination Product (Y/N): N
• Initial Reporter Country: CO
• PMA/510(K) Number: K042126
• 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): 01/08/2021

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
• Operator of Device: No Information
• Device Expiration Date: 03/31/2022
• Device Model Number: IPN914865
• Device Catalogue Number: PS-01652
• Device Lot Number: 14F20C0227
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 01/08/2021
• Supplement Date Received by Manufacturer: 02/18/2021
• Initial Report FDA Received Date: 01/27/2021
• Supplement Report FDA Received Date: 02/18/2021
• 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: NOT REPORTED.; NOT REPORTED.; NOT REPORTED.
• Outcome Attributed to Adverse Event: Other