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

Model Number	5534190
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/04/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, a manufacturing review could not be performed.The sample was returned to the manufacturer for evaluation, the investigation is currently under way.
Event or Problem Description
It was reported that the catheter was allegedly leaking.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: neither a lot history review nor a complete dhr review could be performed as the lot number was not provided.Investigation summary: one 19cm vas-cath catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for an external, as leaking was observed in both lumens during infusion against resistance.Two holes were found just distal to the bifurcation and the break surfaces were observed to be rough and granular.The break surface characteristics are consistent with catheter tears as result of repeated/prolonged excessive mechanic stresses on the catheter.The definitive root cause could not be determined based upon available information.Repeated/prolonged excessive mechanical stresses and/or torques may have contributed to the observed holes.It is unknown if procedural issues contributed to the reported event.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 or Problem Description
It was reported that the catheter was allegedly leaking.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: 8494042
• Report Number: 3006260740-2019-00813
• Device Sequence Number: 1783445
• 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): 06/17/2019

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: 03/22/2019
• Initial Date Received by Manufacturer: 03/12/2019
• Supplement Date Received by Manufacturer: 05/24/2019
• Initial Report FDA Received Date: 04/08/2019
• Supplement Report FDA Received Date: 06/17/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1