MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F

Model Number	5835190
Medical Device Problem Codes	Fluid/Blood Leak (1250); Fracture (1260)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	06/10/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was not provided, 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 sometime post catheter implant, the hemostar catheter was allegedly found to leak around the cuff.However, no issues were found when placing the catheter.The procedure was completed by replacing it with a new catheter.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: a device history record review could not be performed as the lot number is unknown investigation summary: one hemostar d/l catheter in two segments was returned for evaluation.Gross visual, microscopic visual and functional evaluations were performed.The investigation is confirmed for catheter break as small portion of the catheter break had a uneven and rough surface consistent with catheter tearing and the break was noted near the cuff.The rest of the break smooth surface and striations.A complete circumferential break was noted approximately 7.5cm from the distal end of the y-body.The distal segment measured approximately 21.9cm in length.A distinct curve of the catheter was noted on the distal catheter segment.The tissue cuff was intact and had residue.However, the investigation is inconclusive for fluid leak as there is no evidence to confirm for the issue.A definitive root cause could not be determined based upon 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: g4 h11: d2,h6(method,result and 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 sometimes post chronic catheter implantation procedure, the device allegedly leaked.It was further reported that the procedure was completed by replacing it with a new catheter.There was no reported patient injury.

• Brand Name: HEMOSTAR LONG-TERM HEMODIALYSIS CATHETER, POLYURETHANE, KIT, 14.5F
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10294077
• Report Number: 3006260740-2020-02569
• Device Sequence Number: 16795036
• Product Code: MSD
• UDI-Device Identifier: 00801741013492
• UDI-Public: (01)00801741013492
• Combination Product (Y/N): N
• Initial Reporter Country: NL
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/27/2020

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: 5835190
• Device Catalogue Number: 5835190
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/17/2020
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 10/19/2020
• Initial Report FDA Received Date: 07/20/2020
• Supplement Report FDA Received Date: 10/27/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1