MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OTW, XK, 23CM, ST, SPLIT TIP, STANDARD KIT; DIALYSIS

Model Number	5913230
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	03/11/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The lot number of the device was provided.The device history records are currently under review.The device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that upon opening the returned hemodialysis catheter kit, the tunneler tip was found allegedly broken.There was no patient contact.
Event or Problem Description
It was reported that upon opening the returned hemodialysis catheter kit, the tunneler tip was found allegedly broken.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 confirmed for damaged/defective tunneler, as a break was noted on connecter of tunneler.The exact root cause for the damaged tunneler could not be determined.However, it is likely that supplier issues may have contributed to reported event.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.

• Brand Name: OTW, XK, 23CM, ST, SPLIT TIP, STANDARD KIT
• Common Device Name: DIALYSIS
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8450069
• Report Number: 3006260740-2019-00666
• Device Sequence Number: 19586521
• 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): 06/26/2019

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: 02/26/2019
• Initial Date Received by Manufacturer: 03/11/2019
• Supplement Date Received by Manufacturer: 06/20/2019
• Initial Report FDA Received Date: 03/25/2019
• Supplement Report FDA Received Date: 06/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1