MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SFTCEL-PC RJ 19CM KIT; DIALYSIS CATHETER

Model Number	5534190
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/16/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was not provided; therefore, a review of the device history records could not be performed.The return of the sample is pending.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that some time post dialysis catheter placement, the catheter allegedly experienced leakage.It was further reported that the catheter was removed.There was no reported patient injury.
Additional 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.A visual, microscopic and functional evaluations were performed.The investigation is confirmed for alleged catheter leak issue as a compound split was noted to the blue extension leg approximately 1.2cm proximal to the y-body.Striations were noted at the edge of the compound break.Both lumens were patent to infusion and aspiration, with a leak noted at the split.Although a definitive root cause could not be determined, sharp instrument damage could have potentially caused or contributed to the reported event.Labeling review: a review of product labeling documentation (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) did not find any product labeling inadequacy.H10: g4.H11: d10, h3, h6 (method, 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.
Event or Problem Description
It was reported that some time post dialysis catheter placement, the catheter allegedly experienced leakage.It was further reported that the catheter was removed.There was no reported patient injury.

• Brand Name: SFTCEL-PC RJ 19CM KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9941566
• Report Number: 3006260740-2020-01224
• Device Sequence Number: 2900410
• 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): 09/10/2020

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: 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: 04/30/2020
• Initial Date Received by Manufacturer: 03/16/2020
• Supplement Date Received by Manufacturer: 09/07/2020
• Initial Report FDA Received Date: 04/08/2020
• Supplement Report FDA Received Date: 09/10/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1