MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SOFT CELL DOUBLE LUMEN DIALYSIS; SOFT CELL D/L DIALYSIS

Model Number	5534190
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/01/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records and no medical images were provided to the manufacturer.The lot number for the device was not provided, therefore, the device history records were not reviewed.The return of the device is pending.The investigation is currently under way.
Event or Problem Description
It was reported that approximately eleven months after the soft cell dialysis catheter was placed during administration of heparin saline, the catheter was identified to be allegedly deformed and discolored.It was further reported a few weeks after the reported issue occurred the device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one soft-cell dual-lumen catheter was returned for evaluation.Catheter was returned with both clamps and tissue cuff intact.Yellow discoloration was noted throughout the extension legs, including the blue luer hub and the bifurcation.Bulging was noted on the lumen of both extension legs and a crack was noted on the soft cell bifurcation.Based on these findings, the investigation is confirmed for the reported catheter aneurysm.It is likely that the identified crack on the bifurcation occurred as a result of the same damage that led to the discoloration and catheter aneurysm, as the bifurcation is a flexible material.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Based on the evaluation, potential contributing factors include over-pressurization and chemical degradation.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.
Event or Problem Description
It was reported that approximately eleven months after the soft cell dialysis catheter was placed during administration of heparin saline, the catheter was identified to be allegedly deformed and discolored.It was further reported a few weeks after the reported issue occurred the device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a complete manufacturing review could not be performed, as the lot number is unknown.Investigation summary: one soft-cell dual-lumen catheter was returned for evaluation and two photos were provided for review.The device was returned with both clamps and tissue cuff intact.Yellow discoloration was noted throughout the extension legs, including the blue luer hub and the bifurcation.Bulging was noted on the lumen of both extension legs and a crack was noted on the soft cell bifurcation.The bulging and discoloration can also be seen in the provided photos.Based on these findings, the investigation is confirmed for the reported catheter aneurysm.It is likely that the identified crack on the bifurcation occurred as a result of the same damage that led to the discoloration and catheter aneurysm, as the bifurcation is a flexible material.However, the definitive root cause could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the reported event.Based on the evaluation, potential contributing factors include over-pressurization and chemical degradation.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.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
It was reported that approximately eleven months after the soft cell dialysis catheter was placed during administration of heparin saline, the catheter was identified to be allegedly deformed and discolored.It was further reported a few weeks after the reported issue occurred the device was removed and replaced.There was no reported patient injury.

• Brand Name: SOFT CELL DOUBLE LUMEN DIALYSIS
• Common Device Name: SOFT CELL D/L DIALYSIS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8149092
• Report Number: 3006260740-2018-03554
• Device Sequence Number: 11253079
• 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
• Device Implanted Year: 2017
• Device Explanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 04/09/2019

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: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/19/2018
• Initial Date Received by Manufacturer: 11/13/2018
• Supplement Date Received by Manufacturer: 03/27/2019; 04/08/2019
• Initial Report FDA Received Date: 12/10/2018
• Supplement Report FDA Received Date: 03/29/2019; 04/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1