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	03/12/2019
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 the tunneler tip allegedly broke within the catheter.There was no reported patient injury.
Event or Problem Description
It was reported that the tunneler tip allegedly broke within the catheter.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.Received 5 complaints reported for this lot number to date.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged broken tunneler as no objective evidence has been provided to confirm any alleged deficiency with the tunneler.The root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.Possible contributing factors include damaged during production and damaged prior to use; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).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.
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.Received 5 complaints reported for this lot number to date.Investigation summary: the device was not returned for evaluation.Images and medical records were not provided for review.Therefore, the investigation is inconclusive for the alleged broken tunneler as no objective evidence has been provided to confirm any alleged deficiency with the tunneler.The root cause could not be determined based upon available information.It is unknown whether procedural factors contributed to the event.Possible contributing factors include damaged during production and damaged prior to use; however, the lack of a returned sample prevented both confirmation of the reported event and identification of a root cause(s).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.(expiration date: 07/2020).
Event or Problem Description
It was reported that the tunneler tip allegedly broke within the catheter.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: 8524117
• Report Number: 3006260740-2019-00893
• Device Sequence Number: 11230409
• Product Code: MSD
• UDI-Device Identifier: 00801741013690
• UDI-Public: (01)00801741013690
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/02/2019

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: RECZ0716
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/21/2019
• Supplement Date Received by Manufacturer: 06/05/2019; 06/05/2019
• Initial Report FDA Received Date: 04/17/2019
• Supplement Report FDA Received Date: 07/02/2019; 07/02/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1