MAUDE Adverse Event Report: ANGIODYNAMICS BIOFLO DIALYSIS CATHETER; CATHETER, HEMODIALYSIS, IMPLANTED

Catalog Number	10302804
Medical Device Problem Codes	Crack (1135); Gas/Air Leak (2946)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
A clinical specialist manager reported a distributor had been notified of six events associated with bioflo duramax dialysis catheters.They related that some of the dialysis sites where patients present in (b)(6) have experienced "cracked/broken hubs" and "air in the bloodline" such that the catheters had to be replaced.They indicated there have been 6 catheters with this problem.None of the patients experienced adverse effects, harm, or require medical intervention as a result of the incidents.It was noted that these instances only occurred at sites away from the main facility where the patients receive hemodialysis.
Additional Manufacturer Narrative
It was reported that the disposable device is not available to be returned to the manufacturer for evaluation.The results of the investigation will be sent via a follow up medwatch.Reference (b)(4).For each of the 6 occurrences/devices, reference: (b)(4), 1317056-2023-00038.(b)(4), 1317056-2023-00039.(b)(4), 1317056-2023-00040.(b)(4), 1317056-2023-00041.(b)(4), 1317056-2023-00042.
Additional Manufacturer Narrative
As the reported device was not returned, angiodynamics is unable to perform a device evaluation.The customer's reported complaint description of extension tubing leaked and air bubbles cannot be confirmed, no sample was returned.Without receiving product for evaluation, we are unable to definitively determine a root cause for this incident.A potential root cause for this type of reported failure is a fracture of the extension tubing adjacent to the luer hub.Excessive torquing of this connection and/or not allowing cleaning agents to completely dry can be contributing factors for fracture of the extension tubing at this location.A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.  the review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.A review of the angiodynamics complaint system noted no adverse trends for this complaint type and product family.This type of complaint will continue to be monitored for trends.Reference (b)(4).For each of the 6 occurrences/devices, reference: (b)(4) 1317056-2023-00038; (b)(4) 1317056-2023-00039; (b)(4) 1317056-2023-00040; (b)(4) 1317056-2023-00041; (b)(4) 1317056-2023-00042; (b)(4) 1317056-2023-00043.
Additional Manufacturer Narrative
A review of the device history records was performed for the indicated lots for any deviations related to the reported failure mode of the complaint.The review confirms that the lots met all material, assembly and performance specifications; i.E.No ncr associated with reported failure mode.Reference (b)(4).Additional information: d4 h4 for each of the 6 occurrences/devices, reference: (b)(4) 1317056-2023-00038.(b)(4) 1317056-2023-00039.(b)(4) 1317056-2023-00040.(b)(4) 1317056-2023-00041.(b)(4) 1317056-2023-00042.(b)(4) 1317056-2023-00043.
Additional Manufacturer Narrative
Correction: device history records review: the customer did not provide an item number nor a lot number for the reported device.Without an item number, angiodynamics was unable to perform a ship history review for lot numbers shipped to the customer.As a result of no lot numbers, we are unable to perform device history records reviews.Reference (b)(4).For each of the 6 occurrences/devices, reference: (b)(4) 1317056-2023-00038 (b)(4) 1317056-2023-00039 (b)(4) 1317056-2023-00040 (b)(4) 1317056-2023-00041 (b)(4) 1317056-2023-00042 (b)(4) 1317056-2023-00043.

• Brand Name: BIOFLO DIALYSIS CATHETER
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer (Section G): ANGIODYNAMICS; 10 glens falls technical park; glens falls, ny 12801 NY 12801
• Manufacturer Contact: alexandra invencio ; 26 forest street; marlborough, MA 01752 ; 5086587990
• MDR Report Key: 16646043
• Report Number: 1317056-2023-00043
• Device Sequence Number: 17522015
• Product Code: MSD
• UDI-Device Identifier: H965103028041
• UDI-Public: H965103028041
• Combination Product (Y/N): N
• Initial Reporter Country: AU
• PMA/510(K) Number: K131260
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 08/08/2023

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: 01/31/2024
• Device Catalogue Number: 10302804
• Device Lot Number: 5702806
• 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: 03/15/2023
• Supplement Date Received by Manufacturer: 04/27/2023; 06/13/2023; 08/01/2023
• Initial Report FDA Received Date: 03/30/2023
• Supplement Report FDA Received Date: 04/28/2023; 06/13/2023; 08/08/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2021
• 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
• Patient Sex: Unknown