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

Model Number	5903230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number for the device was provided.The device history records are currently under review.The return of the device is pending.The investigation is currently underway.
Event or Problem Description
It was reported that when tunneling the catheter, the white tip of the tunneler allegedly broke.Reportedly, a new kit was opened to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that when tunneling the catheter, the white tip of the tunneler allegedly broke.Reportedly, a new kit was opened to complete the procedure.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 associated with this problem in regards to product materials or during packaging, manufacturing or qc inspection processes.All necessary inspections were performed throughout all the manufacturing, packaging and inspection activities and for raw material utilized in the manufacture of this lot, in regards to the described problem.Investigation summary: four 14.5 fr d/l equistream 23 cm str hemodialysis catheter with surecuff kits were returned for evaluation.One of the samples was an original sample and three of the samples were lot samples.Functional, gross visual, microscopic visual and tactile evaluation were performed.The investigation is confirmed for damaged/defective tunneler, as the sample evaluation confirmed that the original sample had a tunneler with a broken catheter loading plastic tip.During processing of the lot samples during the preliminary evaluation, one of plastic tunneler tips from one of the lot samples fractured and it was noted the plastic tip seemed brittle.This is known issue for chronic dialysis catheter tunneler plastic tips.The definitive root cause could not be determined based upon available information.However, it is likely that supplier related issues contributed to the reported event.Corrective action has been issued to turnxon precision co.Ltd to address the issue and identify appropriate actions.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.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: OTW, 14.5 FR, 23CM, ST, SPLIT TIP, STANDARD KIT
• Common Device Name: LONG-TERM HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8417353
• Report Number: 3006260740-2019-00550
• Device Sequence Number: 16547136
• Product Code: MSD
• UDI-Device Identifier: 00801741013706
• UDI-Public: (01)00801741013706
• Combination Product (Y/N): N
• Initial Reporter State: OR
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/16/2019

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: 5903230
• Device Catalogue Number: 5903230
• Device Lot Number: RECW0847
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/11/2019
• Initial Date Received by Manufacturer: 02/14/2019
• Supplement Date Received by Manufacturer: 05/15/2019
• Initial Report FDA Received Date: 03/13/2019
• Supplement Report FDA Received Date: 05/16/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1