MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD KIT; DIALYSIS CATHETER

Model Number	5903190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	03/06/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing review: per the lot history review, this is the third complaint reported for this lot number and issue to date.The quantity affected is one.Based upon the severity level and lot quantity, a dhr review is required.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.Investigation summary: per manufacturing site: 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.Based on the sample evaluation: one equistream catheter and one tunneler were returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as the proximal end of the tunneler was broken off and missing from the rest of the device.The break surface was observed to be smooth and uneven.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.(expiration date: 08/2020).
Event or Problem Description
It was reported that the tip of the tunneler component broke in the catheter during the insertion process.It was further reported that a new kit was used where the tunneler component broke a second time during the same process.There was no reported patient injury.

• Brand Name: OTW, 14.5 FR, 19CM, 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: 8474885
• Report Number: 3006260740-2019-00754
• Device Sequence Number: 16512428
• Product Code: MSD
• UDI-Device Identifier: 00801741013690
• UDI-Public: (01)00801741013690
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 04/02/2019

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: 5903190
• Device Catalogue Number: 5903190
• Device Lot Number: RECZ3009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/12/2019
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/06/2019
• Initial Report FDA Received Date: 04/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Weight: 107