MAUDE Adverse Event Report: BARD ACCESS SYSTEMS EQUISTREAM XK CATHETER 19 CM, 19 CM STRAIGHT DL W AIRGUARD; 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	03/21/2019
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 device has been returned for evaluation.The investigation is currently underway.
Event or Problem Description
It was reported that upon opening, the package the blue part of the tunneler was allegedly broken.Reportedly, a new kit was opened to complete the procedure.There was no patient contact.
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.Investigation summary: one 19cm equistream xk catheter with insertion stylet in the red lumen, one tunneler, one 17.5f dilator, one 16f dilator, one 12f dilator, one 8f dilator, and one 16.5f airguard valved introducer peel-apart sheath and dilator 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 a break was noted on the blue part 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.Corrective action has been issued to turnxon precision co.Ltd to address the damaged tunneler 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: 07/2020).
Event or Problem Description
It was reported that upon opening the package the blue part of the tunneler was allegedly broken.Reportedly, a new kit was opened to complete the procedure.There was no patient contact.

• Brand Name: EQUISTREAM XK CATHETER 19 CM, 19 CM STRAIGHT DL W AIRGUARD
• 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: 8550274
• Report Number: 3006260740-2019-01148
• Device Sequence Number: 1731196
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/23/2019

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/17/2019
• Initial Date Received by Manufacturer: 04/01/2019
• Supplement Date Received by Manufacturer: 05/22/2019
• Initial Report FDA Received Date: 04/25/2019
• Supplement Report FDA Received Date: 05/23/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1