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
No medical records and no medical images were provided to the manufacturer.The lot number for the device was provided.The device history records are currently under review.The device has been returned for evaluation.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: manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.Investigation summary: based on the sample evaluation: one equistream 14.5 fr, 23 cm, split tip long term hemodialysis dual lumen catheter was returned for evaluation.Visual, microscopic, tactile and functional evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as the device examination showed an obstruction in the distal, tunneler attachment segment of the blue lumen distal catheter tip.The 0.22 ins obstruction was not flushed out or removed so as not to disturb the evidence.This together with the remaining stub measurement of 0.25 ins indicates an approximate 0.3 ins length missing from the tunneler connection attachment.Microscopic evaluations provided confirmation of the gross visual observations in particular the evidence of a fragment of apparent tunneler attachment tip in the appropriate segment of the catheter.The definitive root cause for the reported damaged tunneler issue could not be determined based upon available information.It is unknown whether patient and/or procedural issues contributed to the event.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.

• 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: 8213987
• Report Number: 3006260740-2018-03790
• Device Sequence Number: 2792129
• 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): 03/21/2019

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: 12/27/2018
• Initial Date Received by Manufacturer: 12/07/2018
• Supplement Date Received by Manufacturer: 03/13/2019
• Initial Report FDA Received Date: 01/03/2019
• Supplement Report FDA Received Date: 03/21/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1