MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HICK HEMO 13.5FR CATH 45CM; DIALYSIS CATHETER

Model Number	0600450
Medical Device Problem Codes	Defective Component (2292); Device Dislodged or Dislocated (2923); Expulsion (2933); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number was not provided, therefore a lot history review was not performed.The sample was not returned for evaluation, therefore the investigation is inconclusive for the reported failure.The definitive root cause is unknown.The device has been labeled for single use.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 600450 dialysis catheter allegedly experienced defective component and dislodgment.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.
Event or Problem Description
This report summarizes one malfunction.A review of the reported information indicated that model 0600450 dialysis catheter allegedly failed to adhere to the tissue and resulted in catheter dislodgment.This information was received from one source.One patient was involved and there was no reported patient injury.Patient information was not provided.
Additional Manufacturer Narrative
H10: the lot number for the reported malfunction was not provided, therefore, a lot history review could not be performed.The device was not returned for evaluation, therefore, the investigation is inconclusive for the reported catheter expulsion and failed tissue in-growth.Based on the available information, the definitive root cause is unknown.The device is labeled for single use.H10: g3, h6(method, conclusion) h11: b5, g1, h6(device) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.

• Brand Name: HICK HEMO 13.5FR CATH 45CM
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V.; blvd montebello #1; parque industrial colonial; reynosa tamaulipas 88780 ; MX 88780
• Manufacturer Contact: judith ludwig ; 1415 w. 3rd street; tempe, AZ 85281 ; 4803032689
• MDR Report Key: 9200130
• Report Number: 3006260740-2019-03076
• Device Sequence Number: 14217425
• Product Code: LJS
• UDI-Device Identifier: 00801741037443
• UDI-Public: (01)00801741037443
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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: 0600450
• Device Catalogue Number: 0600450
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 03/31/2022
• Initial Report FDA Received Date: 10/16/2019
• Supplement Report FDA Received Date: 04/11/2022
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown