MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPTRACK; CATHETER INTRAVASCULAR THERAPE

Model Number	IPN037877
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/25/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn# (b)(4).
Event or Problem Description
Customer reports "after picc placed very difficult to remove wire.Picc line was retracted until wire could be removed.Rn noted wire was jagged and rough when ran finger along the line." no patient injury or consequence reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.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.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
Event or Problem Description
Customer reports "after picc placed very difficult to remove wire.Picc line was retracted until wire could be removed.Rn noted wire was jagged and rough when ran finger along the line." no patient injury or consequence reported.The patient's condition is reported as fine.

• Brand Name: ARROW PI PICC KIT: 2L 5.5FR 55CM AGBA TIPTRACK
• Common Device Name: CATHETER INTRAVASCULAR THERAPE
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 12312299
• Report Number: 9680794-2021-00398
• Device Sequence Number: 14598818
• Product Code: LJS
• UDI-Device Identifier: 60801902132873
• UDI-Public: 60801902132873
• Combination Product (Y/N): N
• Initial Reporter State: ME
• Initial Reporter Country: US
• PMA/510(K) Number: K160925
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 07/27/2021

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: 05/31/2022
• Device Model Number: IPN037877
• Device Catalogue Number: CDC-45552-TTS
• Device Lot Number: 13F21C0550
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/27/2021
• Supplement Date Received by Manufacturer: 09/14/2021
• Initial Report FDA Received Date: 08/12/2021
• Supplement Report FDA Received Date: 09/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1