MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW CVC SET: 3-LUMEN 7FR X 20CM; CATHETER, PERCUTANEOUS

Model Number	IPN030887
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: row infusion qn#(b)(4).
Event or Problem Description
The complaint is reported as: catheter placed for patient to undergo transplant and after 22 days the catheter was removed "due to pillow was wet".The catheter broke at the brown connection.A second catheter was placed in the operating room and 10 days after it was removed because "it had the same fault".The patient's mother refused another catheter and a picc line was placed.The patient was reported to be fine.
Additional Manufacturer Narrative
Concomitant medical products: row infusionqn# (b)(4).The customer did not return a complaint sample; however, they supplied a photo showing the catheter in use.The reported defect of the extension line and luer hub separation cannot be observed in the image.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.The ifu provided with this kit provides the following warnings, cautions and instructions for the user: "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage." "using catheters not indicated for high pressure injection for such applications can result in inter-lumen crossover or rupture with potential for injury." "do not secure, staple and/or suture directly to outside diameter of catheter body or extension lines to reduce risk of cutting or damaging the catheter or impeding catheter flow.Secure only at indicated stabilization locations." "do not alter the catheter, guidewire or any other kit/set component during insertion, use or removal." "do not cut catheter to alter length." the reported complaint of a catheter "extension line/luer hub separation" could not be confirmed through examination of the customer supplied photo and without the sample returned for evaluation.The customer image showed the catheter in use; however, the photo did not show the reported defect of the extension line/luer hub separation and the complaint sample was not returned for evaluation.A device history record review was performed based on a potential lot number identified from sales history with no evidence to suggest a manufacturing related cause.The probable cause of the reported complaint could not be determined based upon the information provided and without the actual complaint sample returned for evaluation.Teleflex will continue to monitor and trend for reports of this nature.
Event or Problem Description
The complaint is reported as: catheter placed for patient to undergo transplant and after 22 days the catheter was removed "due to pillow was wet".The catheter broke at the brown connection.A second catheter was placed in the operating room and 10 days after it was removed because "it had the same fault".The patient's mother refused another catheter and a picc line was placed.The patient was reported to be fine.

• Brand Name: ARROW CVC SET: 3-LUMEN 7FR X 20CM
• Common Device Name: CATHETER, PERCUTANEOUS
• Manufacturer (Section D): ARROW INTERNATIONAL INC.; reading PA
• MDR Report Key: 11424837
• Report Number: 3006425876-2021-00198
• Device Sequence Number: 14472249
• Product Code: DQY
• UDI-Device Identifier: 00801902000606
• UDI-Public: 00801902000606
• Combination Product (Y/N): N
• Initial Reporter Country: SP
• PMA/510(K) Number: K862056
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/19/2021

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: No Information
• Device Model Number: IPN030887
• Device Catalogue Number: CV-15703-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/19/2021
• Supplement Date Received by Manufacturer: 04/09/2021
• Initial Report FDA Received Date: 03/05/2021
• Supplement Report FDA Received Date: 04/09/2021
• 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: CHEMO, SERUM, ANTIBIOTIC, BLOOD COMPONENTS AND MAR; CHEMO, SERUM, ANTIBIOTIC, BLOOD COMPONENTS AND MAR