MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM; CATHETER,INTRAVASCULAR,THERAP

Model Number	IPN036444
Medical Device Problem Code	Fitting Problem (2183)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Associated mdr#s 680794-2022-00694 for the 2 obturator caps reported.
Event or Problem Description
The complaint is reported as: mac was inserted in the cvor.A day or two later the swan was removed in the icu and an individual ao-09000 (obturator) was used to try and cap off the sheath.The obturator cap would not fit over the psi.Therefore; they were not able to properly secure the psi with obturator cap.The clinician wedged as much of it as they could onto the mac.They also found the extra obturator cap that came inside their mac kit.It did not fit either.The mac was discontinued later that day and no other additional procedure was needed.The mac had reached end of therapy.No patient harm was reported.The patient's condition is reported as fine.
Additional Manufacturer Narrative
Qn#(b)(4).Associated mdr#s 9680794-2022-00694 and 9680794-2022-00712 for the 2 obturator caps reported.Complaint verification testing could not be performed as it was reported that the sample is not available for return.The customer did not provide a lot number; therefore, a device history record review was performed based upon a lot number from the sales history data of the customer.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: mac was inserted in the cvor.A day or two later the swan was removed in the icu and an individual ao-09000 (obturator) was used to try and cap off the sheath.The obturator cap would not fit over the psi; therefore, they were not able to properly secure the psi with obturator cap.The clinician wedged as much of it as they could onto the mac.They also found the extra obturator cap that came inside their mac kit.It did not fit either.The mac was discontinued later that day and no other additional procedure was needed.The mac had reached end of therapy.No patient harm was reported.The patient's condition is reported as fine.

• Brand Name: ARROW MAC KIT: 2-L 9 FR DISTAL X 11.5 CM ANTIM
• Common Device Name: CATHETER,INTRAVASCULAR,THERAP
• 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: 15770712
• Report Number: 9680794-2022-00712
• Device Sequence Number: 15108647
• Product Code: FOZ
• UDI-Device Identifier: 30801902116834
• UDI-Public: 30801902116834
• Combination Product (Y/N): N
• Initial Reporter State: MD
• Initial Reporter Country: US
• PMA/510(K) Number: K011761
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/17/2022

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
• Device Model Number: IPN036444
• Device Catalogue Number: CDC-21242-X1A
• Device Lot Number: N/A
• 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: 10/17/2022
• Supplement Date Received by Manufacturer: 12/05/2022
• Initial Report FDA Received Date: 11/10/2022
• Supplement Report FDA Received Date: 12/06/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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
• Concomitant Medical Products and Therapy/Usage Dates: NOT REPORTED; NOT REPORTED
• Patient Sex: Unknown