MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 24 CM HEMOSPLIT ALPHACURVE STANDARD KIT; DIALYSIS CATHETER

Model Number	5735190
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/24/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device has been provided.A review of the device history records is currently being performed.The device has been returned to the manufacturer for evaluation.The investigation is currently underway.(expiration date: 09/2019).
Event or Problem Description
It was reported approximately two weeks post dialysis catheter placement that the extension leg was allegedly broken.It was further reported that the catheter was removed and a new device was placed.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: a device history record (dhr) review was not required as this is the first complaint for this lot number.Investigation summary: one 24 cm hemosplit alphacurve catheter was returned for evaluation.Functional, gross visual, microscopic visual and tactile evaluations were performed.The investigation is confirmed for a complete circumferential break in the extension leg, as a short segment of extension leg tubing was observed to be extending from the bifurcation, with the rest of the extension leg and blue hub missing.The profile of the break was slightly inclined, and the break surface did not appear to be planar.One region of the break surface appeared to be smooth with parallel striations, whereas the other region of the break surface appeared to be uneven and rougher and more granular.The break edges appeared to be sharp.Blood/tissue residue was observed throughout the device.After flushing out excessive blood residue, both lumens were separately patent to infusion and aspiration and no leaks were observed.The definitive root cause could not be determined based upon available information.The rough and granular regions on the break surface are consistent with tearing of the tubing.In particular, the observed striations on the break surface are consistent with characteristics of intervals of tearing separated by periods of no tearing.It is possible that the extension leg gradually tore, resulting in a complete break.Poor material selection, degradation of catheter extensions (e.G.Repeated and/or prolonged exposure to acetone and peg-containing ointment and/or repeated/excessive tension/compression/shearing forces on the extension leg may have contributed to the observed break in the extension leg.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 approximately two weeks post dialysis catheter placement that the extension leg was allegedly broken.It was further reported that the catheter was removed and a new device was placed.There was no reported patient injury.

• Brand Name: 24 CM HEMOSPLIT ALPHACURVE STANDARD KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8817074
• Report Number: 3006260740-2019-02097
• Device Sequence Number: 10876930
• Product Code: MSD
• UDI-Device Identifier: 00801741013188
• UDI-Public: (01)00801741013188
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 5735190
• Device Catalogue Number: 5735190
• Device Lot Number: REBW1495
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/08/2019
• Initial Date Received by Manufacturer: 06/26/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 07/23/2019
• Supplement Report FDA Received Date: 09/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 68 YR
• Patient Weight: 65