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

Model Number	5704190
Medical Device Problem Codes	Break (1069); Deformation Due to Compressive Stress (2889)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	04/02/2020
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 device has not been returned to the manufacturer for evaluation, however photos have been provided.The investigation of the reported event is currently underway.(expiration date: 11/2021).
Event or Problem Description
It was reported that during a catheter placement, the guide wire was allegedly found to be broken at the bending part.Another device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: per the complaint history review (chr), this is the only complaint reported for this lot number to date.A dhr review is not required.Investigation summary: the sample was not returned for evaluation, one electronic photo was provided for review.The investigation is inconclusive for a guidewire break, as the photo review could not identify a break/fracture in the guidewire.However, the investigation is confirmed for a kink/bend in the guidewire, as the photo review identified a sharp bend and misaligned outer wire coils near the j-tip.The definitive root cause could not be determined based upon available information.Compressive stresses applied to the guidewire could have potentially caused or contributed to the reported event.Labeling review: the cause of the event in question is unknown, and so the applicability of any particular portion of the ifu 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 ifu instructs on the use of the guidewire.Therefore, the product labeling will be considered adequate.H10: d4 (expiration date: 11/2021), g4.H11: h6 (device, method, results & 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 during a catheter placement in the jugular vein, the guide wire was allegedly found to be broken at the bending part.It was further reported that another device was used to complete the procedure.There was no reported patient injury.

• 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: 10002905
• Report Number: 3006260740-2020-01514
• Device Sequence Number: 2968539
• 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: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/09/2020

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: 5704190
• Device Catalogue Number: 5704190
• Device Lot Number: RECZ0656
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/16/2020
• Supplement Date Received by Manufacturer: 07/08/2020
• Initial Report FDA Received Date: 04/27/2020
• Supplement Report FDA Received Date: 07/09/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 56 YR
• Patient Weight: 65