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

Model Number	5835190
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/05/2019
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 device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.A photo review is needed.Expiry date (07/2020).
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.There was no reported patient injury.
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.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: the device history record review was performed for the reported lot number and this lot meets all release criteria.The manufacturing review did not indicate any possible manufacturing issue that could be related to the reported event.Investigation summary: the sample was not returned for evaluation, however, one electronic photo was provided for review.The investigation is inconclusive for reported fluid leak, as the photo shows only a reference picture of the device marked by the end user indicating the area of leak and no original alleged device photo available for evaluation.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: d4 (expiry date: 07/2020),g4 h11: d2,h6(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.

• 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: 10294238
• Report Number: 3006260740-2020-02572
• Device Sequence Number: 14103987
• 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 Implanted Year: 2019
• 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: RECX2774
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/25/2020
• Supplement Date Received by Manufacturer: 10/15/2020
• 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