MAUDE Adverse Event Report: ARROW INTERNATIONAL LLC CATH PKGD: BERMAN 5 FR 80CM; CATHETER, FLOW DIRECTED

Model Number	IPN917235
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/16/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).Medwatch report number not provided.Uf/importer report (b)(4).Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported via a medwatch report that "there was a small hole in the side of the catheter that was outside the body.Contrast was injected through the catheter using a power injector.Power injector settings were confirmed appropriate for the catheter.No harm to the patient, as the defective part of the catheter did not enter the body".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.Medwatch report number not provided.Uf/importer report (b)(4).
Event or Problem Description
It was reported via a medwatch report that "there was a small hole in the side of the catheter that was outside the body.Contrast was injected through the catheter using a power injector.Power injector settings were confirmed appropriate for the catheter.No harm to the patient, as the defective part of the catheter did not enter the body".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.Medwatch report number not provided.Uf/importer report #3902560000-2023-8072.
Additional Manufacturer Narrative
(b)(4).As per the additional information received on 05jul2023, the catheter was initially located at the right atrium of heart and the hole was identified near the hub of the catheter during injection of contrast.The catheter did not inject contrast appropriately as most of the contrast went out of the hole.The catheter was removed and another catheter of same type with larger diameter was used (6fr).The patient had no injury.The reported complaint that "there was a small hole in the side of the catheter that was outside the body" was confirmed based on the customer pictures.It was reported there was no sample available for investigation.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.However, the specifications were not met during the complaint investigation due to the ruptured catheter body.The probable root cause of the complaint is manufacturing related.Capa has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Additional Manufacturer Narrative
(b)(4).The reported complaint that "there was a small hole in the side of the catheter that was outside the body" is confirmed based on the customer pictures.The product was not returned for investigation.A device history record (dhr) review was conducted for the lot number with no relevant findings.The device passed all manufacturing specifications prior to release.However, the specifications were not met during the complaint investigation due to the ruptured catheter body.The probable root cause of the complaint is manufacturing related.Capa has been initiated under teleflex's quality system by the manufacturing site to further investigate this complaint issue.Teleflex will continue to monitor and trend on complaints of this nature.Other remarks: n/a.Corrected data: n/a.
Event or Problem Description
It was reported via a medwatch report that "there was a small hole in the side of the catheter that was outside the body.Contrast was injected through the catheter using a power injector.Power injector settings were confirmed appropriate for the catheter.No harm to the patient, as the defective part of the catheter did not enter the body".At the time of this report, the customer has not returned our requests for additional information.If further information is received, the complaint file will be updated.Medwatch report number not provided.Uf/importer report # (b)(4).

• Brand Name: CATH PKGD: BERMAN 5 FR 80CM
• Common Device Name: CATHETER, FLOW DIRECTED
• Manufacturer (Section D): ARROW INTERNATIONAL LLC; morrisville NC
• Manufacturer (Section G): ARROW INTERNATIONAL INC.; 16 elizabeth drive; chelmsford MA 01824
• Manufacturer Contact: kevin don bosco ; 3015 carrington mill blvd; morrisville 27560
• MDR Report Key: 17238882
• Report Number: 3010532612-2023-00363
• Device Sequence Number: 7241579
• Product Code: DYG
• UDI-Device Identifier: 10801902180787
• UDI-Public: 10801902180787
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K892530
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/11/2023

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: 12/31/2023
• Device Model Number: IPN917235
• Device Catalogue Number: AI-07135
• Device Lot Number: 16F22G0068
• 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: 05/11/2023
• Supplement Date Received by Manufacturer: 07/07/2023; 07/07/2023
• Initial Report FDA Received Date: 06/30/2023
• Supplement Report FDA Received Date: 07/07/2023; 07/10/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/20/2022
• 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: N/A.; N/A.; N/A.
• Patient Age: 4 YR
• Patient Sex: Female