MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT,14.5 FR,ST,27CM,T CUFF,STAND; DIALYSIS CATHETER

Model Number	5733274
Medical Device Problem Codes	Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	07/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The return of the sample is pending; however photo has been provided for review.The investigation of the reported event is currently underway.Expiry date (05/2021).
Event or Problem Description
It was reported that the tube of the catheter allegedly bulged.The procedure was completed using another device.There was no reported patient injury.
Event or Problem Description
It was reported that post catheter placement in right internal jugular vein, the tube of the catheter allegedly bulged.The procedure was completed using another device.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a lot history review was performed.This is the only complaint to date for this lot number.Therefore, a device history record review is not required.Investigation summary: one hemosplit long-term dialysis catheter was returned for evaluation.Visual, microscopic and functional testing were performed.Stretching to the red luer extension leg was noted distal to the distal end of the luer.The sample was returned with both clamps disengaged.The tissue cuff was intact and had residue.Both lumens were patent to infusion and aspiration with no issue.The investigation is confirmed for the bulged catheter, as a bulge on the red luer extension leg was clearly noted.A definitive root cause could not be determined based upon the available information.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: d4 expiry date (05/2021), g4.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: HEMOSPLIT,14.5 FR,ST,27CM,T CUFF,STAND
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10361452
• Report Number: 3006260740-2020-02761
• Device Sequence Number: 19390285
• Product Code: MSD
• UDI-Device Identifier: 00801741013034
• UDI-Public: (01)00801741013034
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 11/29/2020

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: 5733274
• Device Catalogue Number: 5733274
• Device Lot Number: REDY4020
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/11/2020
• Initial Date Received by Manufacturer: 07/13/2020
• Supplement Date Received by Manufacturer: 11/03/2020
• Initial Report FDA Received Date: 08/04/2020
• Supplement Report FDA Received Date: 11/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1