MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT, 14.5 FR, PC, 24CM, STAND KIT; DIALYSIS CATHETER

Model Number	5704190
Medical Device Problem Codes	Material Opacification (1426); Stretched (1601); Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	Swelling (2091)
Date of Event	03/14/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Photo were provided for review.As the lot number for the device was provided, a review of the device history records was not required to be performed.The device has not been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 10/2021).
Event or Problem Description
It was reported that some time post dialysis catheter placement, the catheter wall was allegedly blistering and was at a risk of rupture.It was further reported that the catheter site was treated with an antibiotic for swelling of the surrounding tissues.The patient status is unknown.
Event or Problem Description
It was reported that some time post dialysis catheter placement, the catheter wall was allegedly blistering and was at a risk of rupture.It was further reported that the catheter site was treated with an antibiotic for swelling of the surrounding tissues.The patient status is unknown.
Additional Manufacturer Narrative
H10: manufacturing review: manufacturing records were reviewed and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is confirmed for extension leg opacification and deformation, as the photo review identified a milky white color, bulging and kinking/bending in the extension legs.The reported events and findings from the investigation are consistent with stretched, opacification, extrusion/protrusion and deformation due to compressive stress issues.The definitive root cause could not be determined based upon available information.Labeling review: the cause of the event in question is unknown, and so the applicability of any particular portion of the instructions for use or other labeling is unknown.However, 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 instructions for use instructs on dressing technique and catheter maintenance.Therefore, the product labeling will be considered adequate.H10: g4,h6 (device: 2889) 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, PC, 24CM, STAND KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 10029641
• Report Number: 3006260740-2020-01671
• Device Sequence Number: 766755
• Product Code: MSD
• UDI-Device Identifier: 00801741012914
• UDI-Public: (01)00801741012914
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5704190
• Device Catalogue Number: 5704190
• Device Lot Number: RECX2622
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/08/2020
• Supplement Date Received by Manufacturer: 06/26/2020
• Initial Report FDA Received Date: 05/06/2020
• Supplement Report FDA Received Date: 06/30/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: IODOPHOR, BACTROBAN; IODOPHOR, BACTROBAN
• Outcome Attributed to Adverse Event: Other
• Patient Age: 65 YR
• Patient Weight: 70