MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSTAR 42CM STANDARD KIT; DIALYSIS CATHETER

Model Number	5834420
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that sometime post dialysis catheter placement, when the extension leg was unclamped, the lumen remained collapsed, flat, and narrow, causing restriction of blood flow, reduction in pump speed, and reduction in clearance in the dialysis treatment.It was further reported that the patient continued to received reduced-efficiency dialysis treatments.Reportedly, the device was removed and replaced.There was no reported patient injury.
Additional Manufacturer Narrative
H10:manufacturing review: the lot met all release criteria.Device history record was reviewed and no deviations/issues were identified or associated with this problem in regards to product materials or during manufacturing, packaging or quality control inspection process.All necessary inspections were performed throughout all manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot in regards to the described problem.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.Investigation summary: one electronic photo was reviewed by (b)(6) (bdpi field assurance engineer).The photo shows the extension leg and a portion of the bifurcation of a dialysis catheter.Part of the vascath logo and ¿24 cm¿ can be seen printed on the bifurcation, indicating a vascath 24 cm device.The device in the photo does not match the device alleged in the complaint report.Therefore, the photo review is inconclusive for kink/deformation in extension leg.Although the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is inconclusive for kink/deformation in extension leg, as the device identified in the photo did not match the device alleged in the complaint.The definitive root cause could not be determined based upon available information.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 sometime post dialysis catheter placement, when the extension leg was unclamped, the lumen remained collapsed, flat, and narrow, causing restriction of blood flow, reduction in pump speed, and reduction in clearance in the dialysis treatment.It was further reported that the patient continued to received reduced-efficiency dialysis treatments.Reportedly, the device was removed and replaced.There was no reported patient injury.

• Brand Name: HEMOSTAR 42CM 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: 8862080
• Report Number: 3006260740-2019-02312
• Device Sequence Number: 1811541
• Product Code: MSD
• UDI-Device Identifier: 00801741013461
• UDI-Public: (01)00801741013461
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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: 5834420
• Device Catalogue Number: 5834420
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2019
• Initial Date Received by Manufacturer: 07/10/2019
• Supplement Date Received by Manufacturer: 05/11/2020
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1