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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SFTCEL-PC RS 19CM KIT; DIALYSIS CATHETER
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BARD ACCESS SYSTEMS SFTCEL-PC RS 19CM KIT; DIALYSIS CATHETER Back to Search Results
Model Number 5533190
Device Problems Fluid/Blood Leak (1250); Fracture (1260)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 03/23/2020
Event Type  malfunction  
Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not 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.
 
Event Description
Was reported that some time post dialysis catheter placement, external leak was allegedly found due to suspected catheter tip damage.There was no reported patient injury.
 
Manufacturer Narrative
H10: manufacturing review: a lot history record could not be completed as the lot number was not provided.Investigation summary: one 19cm soft-cell d/l catheter was returned for evaluation.Functional, gross visual and microscopic visual were performed.Two photos were also provided and reviewed.The investigation is confirmed for catheter fracture and external leak, as a small partial fracture was identified at the connection between the bifurcation and catheter shaft.The edges of the fracture were observed to be jagged.Leaking was observed at the partial fracture during in-lab functional testing.The investigation is unconfirmed for material deformation, as no material deformation was identified at the site of the partial fracture.Although a definitive root cause could not be determined, excessive/repeated stresses at the bifurcation-catheter shaft connection could have potentially caused or contributed to the reported event, as the edges of the fracture at the connection are consistent with catheter tearing.Labeling review: a review of product labeling documents (e.G., procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) showed that the product labeling is adequate.
 
Event Description
It was reported that approximately three months nineteen days post dialysis catheter placement, external leak was allegedly found due to suspected catheter tip damage.There was no reported patient injury.
 
Manufacturer Narrative
H10: photos were provided for review.As the lot number for the device was not provided, a review of the device history records could not be performed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.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 Description
It was reported that approximately three months nineteen days post dialysis catheter placement, external leak was allegedly found due to suspected catheter tip damage.There was no reported patient injury.
 
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Brand Name
SFTCEL-PC RS 19CM KIT
Type of Device
DIALYSIS CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key9959670
MDR Text Key195155437
Report Number3006260740-2020-01280
Device Sequence Number1
Product Code LFJ
UDI-Device Identifier00801741012396
UDI-Public(01)00801741012396
Combination Product (y/n)N
PMA/PMN Number
K030277
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup,Followup
Report Date 09/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model Number5533190
Device Catalogue Number5533190
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/15/2020
Date Manufacturer Received09/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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