MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OTW, 14.5 FR, 23CM, ST, SPLIT TIP, STANDARD KIT; DIALYSIS CATHETER

Model Number	5903230
Medical Device Problem Codes	Break (1069); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.(expiration date: 03/2020).
Event or Problem Description
It was reported that the tip of a dialysis catheter allegedly broke off.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot met all release criteria.Dhr was reviewed and no deviations/issues were identified or associated with this problem in regards to product materials or during manufacturing, packaging or qc 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: as this complaint has been found to be manufacturing/supplier related, a review of product labeling documents (e.G.Procedural instructions, indications, warnings, precautions, cautions, possible complications, contraindications, nursing guide, and unit label) is not applicable.Product labeling would not have prevented this issue.Investigation summary:one tunneler and one equistream 23cm catheter were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for broken tunneler tip, as the proximal end of the catheter loading tip on the tunneler was detached.Both break surfaces were jagged.The detached proximal fragment of the tunneler tip was lodged in the catheter distal tip.The exact root cause for the damaged tunneler could not be determined.
Event or Problem Description
It was reported that the tip of a dialysis catheter allegedly broke off.There was no reported patient injury.

• Brand Name: OTW, 14.5 FR, 23CM, ST, SPLIT TIP, 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: 8556106
• Report Number: 3006260740-2019-01198
• Device Sequence Number: 11274911
• Product Code: MSD
• UDI-Device Identifier: 00801741013706
• UDI-Public: (01)00801741013706
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K090101
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 12/09/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 5903230
• Device Catalogue Number: 5903230
• Device Lot Number: RECX3053
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/10/2019
• Initial Date Received by Manufacturer: 04/02/2019
• Supplement Date Received by Manufacturer: 11/12/2019
• Initial Report FDA Received Date: 04/26/2019
• Supplement Report FDA Received Date: 12/09/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: Z-2372-2019
• Patient Sequence Number: 1