MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM ALPHACURVE DL CATHETER 14.5FR, 28CM; LONG-TERM HEMODIALYSIS CATHETER

Model Number	5905280
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
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.Medical device: expiry date: 03/2020.
Event or Problem Description
It was reported the tip of the tunneler allegedly broke.Reportedly, a new device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported the tip of the tunneler allegedly broke.Reportedly, a new device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturing review: the lot met all release criteria.The dhr was reviewed and no deviations or issues were identified associated with this problem in regards to product materials or during packaging, manufacturing or qc inspection processes.Investigation summary: equistream alphacurve d/l catheter 14.5 fr, 28cm hemodialysis catheter with surecuff kit was received with both clamps engaged was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as the proximal tip of the tunneler was broken off.One electronic photo was reviewed as well and showed an overall view of the broken tunneler.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.However, corrective actions are currently open to address the issue and identify appropriate actions.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.Expiry date: 03/2020.

• Brand Name: EQUISTREAM ALPHACURVE DL CATHETER 14.5FR, 28CM
• 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: 8436847
• Report Number: 3006260740-2019-00604
• Device Sequence Number: 2051520
• Product Code: MSD
• UDI-Device Identifier: 00801741013812
• UDI-Public: (01)00801741013812
• Combination Product (Y/N): N
• Initial Reporter State: ND
• 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,Followup
• Report Date (Section B): 05/08/2019

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: 5905280
• Device Catalogue Number: 5905280
• Device Lot Number: RECX2828
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2019
• Initial Date Received by Manufacturer: 02/21/2019
• Supplement Date Received by Manufacturer: 04/30/2019
• Initial Report FDA Received Date: 03/20/2019
• Supplement Report FDA Received Date: 05/08/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1