MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 SOFT-CELL PC-2 DIALYSIS CATHETER KIT, 12.5F, 19CM

Model Number	5534190
Medical Device Problem Codes	Suction Problem (2170); Obstruction of Flow (2423)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s), and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiry date: 06/2022).
Event or Problem Description
It was reported that during a port placement procedure, the blood withdrawal could not be confirmed after inserting the catheter.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during a port placement procedure, the blood withdrawal could not be confirmed after inserting the catheter.It was further reported that another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: the file was reassessed for reportability and determined to be no longer reportable.H10: as the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.H10: d4: (expiry date: 06/2022).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.H3 other text: device not returned.

• Brand Name: SOFT-CELL PC-2 DIALYSIS CATHETER KIT, 12.5F, 19CM
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• MDR Report Key: 10820998
• Report Number: 3006260740-2020-20443
• Device Sequence Number: 16960713
• Product Code: LFJ
• UDI-Device Identifier: 00801741012440
• UDI-Public: (01)00801741012440
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K030277
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/17/2021

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: 5534190
• Device Catalogue Number: 5534190
• Device Lot Number: REEP0938
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 10/19/2020
• Supplement Date Received by Manufacturer: 02/11/2021
• Initial Report FDA Received Date: 11/11/2020
• Supplement Report FDA Received Date: 03/10/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other