MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SFTCEL RS 19CM KIT; DIALYSIS CATHETER

Model Number	5534230
Medical Device Problem Code	Suction Problem (2170)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	10/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was not provided, therefore, the device history records could not be reviewed.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that some time post dialysis catheter placement, the blue luer connector of the dialysis catheter allegedly aspirated air.There was no reported patient injury.
Event or Problem Description
It was reported that some time post dialysis catheter placement, the blue luer connector of the dialysis catheter allegedly aspirated air.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the lot number for the device was not provided, therefore, the device history records could not be reviewed.Investigation summary: one 19cm soft-cell 10f catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is inconclusive for aspiration of air into the blue luer connector, as the sample was observed to be patent to infusion and aspiration with no leaks observed during in-lab functional testing.However, details regarding the location of the air aspiration issue and connection at the blue luer connector were not provided.The surface of the observed complete circumferential break at the distal end of the returned device appeared to be smooth with striations and the edges appeared to be sharp.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the 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.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.

• Brand Name: SFTCEL RS 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: 9312705
• Report Number: 3006260740-2019-03525
• Device Sequence Number: 460069
• Product Code: LFJ
• UDI-Device Identifier: 00801741012457
• UDI-Public: (01)00801741012457
• 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): 03/19/2020

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: 5534230
• Device Catalogue Number: 5533690
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/11/2019
• Initial Date Received by Manufacturer: 10/16/2019
• Supplement Date Received by Manufacturer: 03/18/2020
• Initial Report FDA Received Date: 11/12/2019
• Supplement Report FDA Received Date: 03/19/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1