MAUDE Adverse Event Report: BARD ACCESS SYSTEMS OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD KIT; HEMODIALYSIS CATHETER

Model Number	5903190
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	05/10/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
As the lot number for the device was provided, a manufacturing review will be performed.The sample was not returned to the manufacturer for inspection/evaluation.Therefore, the investigation of the reported event is inconclusive.Based upon the available information, the definitive root cause for this event is unknown.The instructions for use (ifu) is adequate for the reported device/patient code(s) and provides general instructions for use, as well as warnings, precautions and potential complications associated with the device.Upon receipt of new or additional information, a follow-up report will be submitted as applicable.Expiry date (08/2020).
Event or Problem Description
It was reported that during procedure the tunneler tip allegedly broke off in two places as it was being inserted into the peel-a-way sheath.It was also reported that allegedly one of the pieces was still inside the tip of the catheter, therefore the catheter was removed.A new device was used to complete the procedure.There was no reported patient injury.
Event or Problem Description
It was reported that during procedure the tunneler tip allegedly broke off in two places as it was being inserted into the peel-a-way sheath.It was also reported that allegedly one of the pieces was still inside the tip of the catheter, therefore the catheter was removed.A new device was used to complete the procedure.There was no reported patient injury.
Additional Manufacturer Narrative
Manufacturer 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 19cm equistream d/l catheter and a tunneler broken in three segments were returned for evaluation.Gross visual and microscopic visual evaluations were performed.The investigation is confirmed for damaged/defective tunneler, as a middle section and the proximal tip of the tunneler plastic end used to attach the catheter was separated from the tunneler.The proximal tip of the plastic end was found lodged in the distal tip of the catheter.Blood and residue were noted throughout the sample.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.

• Brand Name: OTW, 14.5 FR, 19CM, ST, SPLIT TIP, STANDARD KIT
• Common Device Name: HEMODIALYSIS CATHETER
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 8675547
• Report Number: 3006260740-2019-01561
• Device Sequence Number: 16899193
• Product Code: MSD
• UDI-Device Identifier: 00801741013690
• UDI-Public: (01)00801741013690
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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: Non-Healthcare Professional
• Remedial Action: Recall
• Type of Report: Initial,Followup
• Report Date (Section B): 09/13/2019

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: 5903190
• Device Catalogue Number: 5903190
• Device Lot Number: RECZ3009
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2019
• Initial Date Received by Manufacturer: 05/10/2019
• Supplement Date Received by Manufacturer: 08/29/2019
• Initial Report FDA Received Date: 06/06/2019
• Supplement Report FDA Received Date: 09/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 65 YR