MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER

Model Number	5913230
Medical Device Problem Code	Component Missing (2306)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a review of the device history records is currently being performed.The device is pending return to the manufacturer for evaluation.The investigation of the reported event is currently underway.
Event or Problem Description
It was reported that prior to use on patient, the introducer sheath was allegedly identified to be 15f instead of 16.5f through the packaging.It was further reported that the device was not opened or used.There was no patient contact.
Additional Manufacturer Narrative
Manufacturing review: the device history records have been reviewed and this lot met all release criteria.There was nothing found to indicate there was a manufacturing related cause for this event.Investigation summary: one 16 fr d/l equistream xk hemodialysis x23 cm str catheter with surecuff kit was returned for evaluation.Visual and microscopic evaluations were performed.The investigation is inconclusive for incorrect component, as gross examination showed the peal-apart sheath to be 15.0 fr with 5.35 mm od x 13.2 cm with an 17.6 cm.However, due to the kit being opened upon return it is unknown whether the mixed components could have been mixed up in clinical or packaging return procedure.The most likely root cause is due to a mix-up at the supplier where the incorrect sheath was mixed with the correct sheath.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.
Event or Problem Description
It was reported that prior to use on patient, the introducer sheath was allegedly identified to be 15f instead of 16.5f through the packaging.It was further reported that the device was not opened or used.There was no patient contact.

• Brand Name: EQUISTREAM XK LONG-TERM HEMODIALYSIS CATHETER
• Common Device Name: DIALYSIS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8396876
• Report Number: 3006260740-2019-00478
• Device Sequence Number: 13788371
• Product Code: MSD
• UDI-Device Identifier: 00801741013843
• UDI-Public: (01)00801741013843
• 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,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2019

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 Expiration Date: 06/30/2020
• Device Model Number: 5913230
• Device Catalogue Number: 5913230
• Device Lot Number: RECV3572
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/11/2019
• Initial Date Received by Manufacturer: 02/11/2019
• Supplement Date Received by Manufacturer: 04/01/2019
• Initial Report FDA Received Date: 03/06/2019
• Supplement Report FDA Received Date: 04/11/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1