MAUDE Adverse Event Report: BARD ACCESS SYSTEMS HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F KIT (19CM) (STRAIGHT); CATHETER, HEMODIALYSIS, IMPLANTED

Model Number	5703690
Medical Device Problem Codes	Break (1069); Corroded (1131)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	08/13/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
No medical records or medical images have been made available to the manufacturer.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.The information provided by bard 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 bard.
Event or Problem Description
It was reported that during preparation for intubating the patient, the tunnel needle allegedly had rust on it.There was no reported patient contact.
Additional Manufacturer Narrative
Manufacturing review: manufacturing records were reviewed (dhr, mrr¿s, scrap and mfg.Process changes) and there were not found evidence that the failure mode reported in this complaint is caused by the mfg.Process.Investigation summary: one hemosplit 14.5cm 19cm catheter kit was returned for evaluation.The kit was returned opened.It was noted that the tunneler possessed a reddish-brown residue on its surface.As the residue is consistent with rust, the investigation is confirmed for the reported rust.As the kit was received open, the definitive root cause could not be determined based upon available information.It is unknown whether procedural issues contributed to the reported event.Potential contributing factors include storage conditions and storage of the kit while unsealed.Labeling review: the review of the ifu (instructions for use), indications, warnings, precautions, cautions, possible complications, and contraindications showed that the product labeling is adequate.(expiry date: 02/2019).
Event or Problem Description
It was reported that during preparation for intubating the patient, the tunnel needle allegedly had rust on it.There was no reported patient contact.Another device was used to complete the procedure.

• Brand Name: HEMOSPLIT LONG-TERM HEMODIALYSIS CATHETER 14.5F KIT (19CM) (STRAIGHT)
• Common Device Name: CATHETER, HEMODIALYSIS, IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7853068
• Report Number: 3006260740-2018-02373
• Device Sequence Number: 1950504
• Product Code: MSD
• UDI-Device Identifier: 00801741012884
• UDI-Public: (01)00801741012884
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K030020
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/03/2019

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: 5703690
• Device Catalogue Number: 5703690
• Device Lot Number: REAP1192
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/19/2018
• Initial Date Received by Manufacturer: 08/13/2018
• Supplement Date Received by Manufacturer: 03/27/2019
• Initial Report FDA Received Date: 09/06/2018
• Supplement Report FDA Received Date: 04/03/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1