MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMO CATH 40 CM & PIK; DIALYSIS CATHETER

Model Number	0600690
Medical Device Problem Code	Device Dislodged or Dislocated (2923)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
For the five reported malfunctions, 2 devices are not available for return and the return for the other 3 devices is currently pending.The company is still investigating the issue at this time.
Event or Problem Description
This report summarizes five malfunctions.A review of the reported information indicated that model 0600690 dialysis catheter allegedly experienced a dislodged/dislocated device.This information was received from various sources.All five malfunctions involved a patient with no reported patient injury.Patient information was not provided for any of the patients.
Event or Problem Description
This report summarizes five malfunctions.A review of the reported information indicated that model 0600690 dialysis catheter allegedly experienced a dislodged/dislocated device.This information was received from various sources.All five malfunctions involved a patient with no reported patient injury.Patient information was not provided for any of the patients.
Additional Manufacturer Narrative
H10: the lot number was provided for all five malfunctions; therefore, a lot history review is currently being performed.The sample for 4 malfunctions and a photo for one malfunction has been provided.One malfunction was reassessed and trending device code 1395 (migration) has been added and confirmed for migration, however, inconclusive for dislodgement.Another malfunction was reassessed and trending device code 2933 (expulsion) has been added and confirmed for expulsion.The investigation for remaining three malfunctions was inconclusive for dislodgement.The definitive root cause for the reported events are unknown.The devices are labeled for single use.H10: g4 h11: h6 (device code: 1395 - migration, 2933 ¿ expulsion, results, conclusion).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.
Additional Manufacturer Narrative
H10: for the five reported malfunctions, (b)(4) device is not available for return and the other (b)(4) devices have been returned.The lot number was provided for (b)(4) out of (b)(4) malfunctions; therefore, a lot history review is currently being performed.The company is still investigating the issue at this time.H10: g4, h6 (method) 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.
Event or Problem Description
This report summarizes five malfunctions.A review of the reported information indicated that model 0600690 dialysis catheter allegedly experienced a dislodged/dislocated device.This information was received from various sources.All five malfunctions involved a patient with no reported patient injury.Patient information was not provided for any of the patients.

• Brand Name: HEMO CATH 40 CM & PIK
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9205432
• Report Number: 3006260740-2019-03108
• Device Sequence Number: 11500852
• Product Code: LJS
• UDI-Device Identifier: 00801741037535
• UDI-Public: (01)00801741037535
• 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,Followup
• Report Date (Section B): 04/21/2020

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: 0600690
• Device Catalogue Number: 0600690
• Device Lot Number: RECV3134, REDP4543
• Initial Date Received by Manufacturer: 09/30/2019
• Supplement Date Received by Manufacturer: 12/31/2019; 03/26/2020
• Initial Report FDA Received Date: 10/17/2019
• Supplement Report FDA Received Date: 01/16/2020; 04/21/2020
• Patient Sequence Number: 1