MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM XK CATHETER 19 CM, 19 CM TRAIGHT DL W AIRGUAD; LONG-TERM HEMODIALYSIS CATHETER

Model Number	5913190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	04/11/2019
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.(expiry date: 07/2020).
Event or Problem Description
It was reported that upon opening the package the tip of the tunneler was allegedly broken.Reportedly, a new device was used to complete the procedure.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: a dhr review is required.The lot met all release criteria.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 manufacturing process.Investigation summary: a sample evaluation could not be performed as the samples were not returned therefore the investigation is inconclusive due to the fact that no sample was returned for evaluation.The root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the event.Possible contributing factors include improper selection, improper dimensional design, effects of shipping and handling not accounted for; 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.(expiry date: 07/2020).
Event or Problem Description
It was reported that upon opening the package the tip of the tunneler was allegedly broken.Reportedly, a new device was used to complete the procedure.There was no patient contact.

• Brand Name: EQUISTREAM XK CATHETER 19 CM, 19 CM TRAIGHT DL W AIRGUAD
• 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: 8587111
• Report Number: 3006260740-2019-01287
• Device Sequence Number: 11195448
• Product Code: MSD
• UDI-Device Identifier: 00801741013836
• UDI-Public: (01)00801741013836
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2019

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: 5913190
• Device Catalogue Number: 5913190
• Device Lot Number: RECX3045
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 04/12/2019
• Supplement Date Received by Manufacturer: 06/27/2019
• Initial Report FDA Received Date: 05/07/2019
• Supplement Report FDA Received Date: 07/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1