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	03/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Qn (b)(4).
Event or Problem Description
The complaint is reported as: "extension line/luer hub separation".The catheter was removed and a picc line was placed.It was reported there was no consequence for the patient.
Event or Problem Description
The complaint is reported as: "extension line/luer hub separation" the catheter was removed and a picc line was placed.It was reported there was no consequence for the patient.
Additional Manufacturer Narrative
(b)(4).The customer returned one 3-lumen cvc for evaluation.Signs of use in the form of biological material were observed inside the extension lines.Visual analysis revealed that the distal extension line contained a hole directly adjacent to the luer hub.Microscopic examination confirmed the hole.No other defects or anomalies were observed.The total catheter length measured 622 mm, which is not within the specification limits of 207-227 mm per the catheter graphic.This aligns with information received from the sales rep that the hospital returned the incorrect sample.The distal extension line inner diameter measured 0.056", or 1.4224 mm, which is within the specification limits of 1.42-1.50 mm per the extension line extrusion graphic.The distal extension line outer diameter measured 2.198 mm, which is within the specification limits of 2.13-2.21 mm per the extension line extrusion graphic.A lab inventory syringe was used to inject water through all three extension lines per ifu which states, "flush each lumen with sterile normal saline for injection to establish patency and prime lumen(s)." when injecting the distal lumen, water was observed exiting out of the hole in the extension line.No defects or anomalies were observed when injecting the proximal and medial lumens.A manual tug test confirmed that all three extension lines were secure within their respective luer hubs.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 instructions for use (ifu) provided with this kit warns the user, "do not apply excessive force in placing or removing catheter or guidewire.Excessive force can cause component damage or breakage.If damage is suspected or withdrawal cannot be easily accomplished, radiographic visualization should be obtained and further consultation requested.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." the customer report of an extension line leak was confirmed by functional and visual inspection of the returned sample.The distal extension line contained a tear adjacent to the luer.A device history record review was performed based on sales history, and no relevant findings were identified.Even though the incorrect catheter was returned, a capa has previously been initiated due to an increasing trend of cvc extension line leaks and separations.The root cause of this issue has not yet been determined.Teleflex will continue to monitor and trend reports of this nature.

• 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: 11679723
• Report Number: 3006425876-2021-00314
• Device Sequence Number: 19606850
• 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): 03/26/2021

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 Model Number: IPN030887
• Device Catalogue Number: CV-15703-E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/30/2021
• Initial Date Received by Manufacturer: 03/26/2021
• Supplement Date Received by Manufacturer: 05/13/2021
• Initial Report FDA Received Date: 04/16/2021
• Supplement Report FDA Received Date: 05/14/2021
• 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: NONE REPORTED; NONE REPORTED; NONE REPORTED