MAUDE Adverse Event Report: BARD ACCESS SYSTEMS VACCESS, ST, 14.5 FR, 23 CM, STANDARD KIT; DIALYSIS CATHETER

Model Number	5103230
Medical Device Problem Codes	Fracture (1260); Material Separation (1562); Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/01/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Photos were provided for review.As this is the only complaint associated with this lot number, a device history record review will not be required.The device has been returned to the manufacturer for evaluation.The investigation of the reported event is currently underway.(expiration date: 05/2021).
Event or Problem Description
It was reported that during dialysis catheter placement, during tunneling, plastic sleeve of the tunneler allegedly broke.There was no reported patient injury.
Additional Manufacturer Narrative
H10: manufacturing review: as the lot number for the device was provided, a manufacturing review will be performed.Investigation summary: one tunneler was returned for evaluation.A gross visual evaluation was performed.The investigation is confirmed for broken tunneler sheath, as a complete circumferential break and a longitudinal crack were identified.The complete break was identified near the tapered end and appeared to have jagged break edges.The longitudinal crack appeared to go through the thickness of the tunneler sleeve wall and appeared to traverse the whole length of the longer fragment.The shorter fragment with the tapered end was on the proximal end of the tunneler with the tapered end oriented distally.The returned sample appeared to be clean.The reported event and findings from the sample evaluation are consistent with fracture and material separation issues.Two photos were also provided and were reviewed.One photo shows labeling for a vaccess lt long-term hemodialysis catheter.Another photo shows a malleable tunneler and tunneler sleeve.The tunneler sleeve is separated into two fragments by a circumferential break.The shorter fragment with the tapered end is on the proximal end of the tunneler with the tapered end oriented distally.The longer fragment is not on the tunneler and appears to have longitudinal crack that extends through the entire fragment.The tunneler is bent in a u-shape near the middle.Based on the photo review, a complete circumferential break and longitudinal crack in the tunneler sleeve can be confirmed.The definite root cause could not be determined based upon available information.It is unknown whether patient and/or procedural factors contributed to the 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.H10: d4 (expiration date: 05/2021); g4.H11: h3, h6 (results and conclusion) h11:section a through f - the information provided by bd represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
Event or Problem Description
It was reported that during dialysis catheter placement, during tunneling, plastic sleeve of the tunneler allegedly broke.There was no reported patient injury.

• Brand Name: VACCESS, ST, 14.5 FR, 23 CM, STANDARD KIT
• Common Device Name: DIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 9384082
• Report Number: 3006260740-2019-03723
• Device Sequence Number: 2219916
• Product Code: MSD
• UDI-Device Identifier: 00801741010668
• UDI-Public: (01)00801741010668
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: K051748
• 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): 03/23/2020

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: 5103230
• Device Catalogue Number: 5103230
• Device Lot Number: REDU0479
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2019
• Initial Date Received by Manufacturer: 11/04/2019
• Supplement Date Received by Manufacturer: 03/20/2020
• Initial Report FDA Received Date: 11/27/2019
• Supplement Report FDA Received Date: 03/23/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 74 YR