MAUDE Adverse Event Report: BARD ACCESS SYSTEMS SOFT-CELL DIALYSIS CATHETER KIT 12.5F X 19 CM (STRAIGHT) (LONG-TERM) (DUAL-LUMEN; CATHETER, SUBCLAVIAN

Model Number	5533690
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	12/23/2015
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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.The device has not been returned to the manufacturer for evaluation; as the device was discarded at (b)(4) due to expire of stock period after visual inspection.A lot history review (lhr) of rezg0389 showed no other similar product complaint(s) from this lot number.Discarded at (b)(4) due to the expire of stock period after visual inspection.
Event or Problem Description
It was reported that the pin hall on the catheter placed out side of the patient body was found when it was placed.The catheter was removed.

• Brand Name: SOFT-CELL DIALYSIS CATHETER KIT 12.5F X 19 CM (STRAIGHT) (LONG-TERM) (DUAL-LUMEN
• Common Device Name: CATHETER, SUBCLAVIAN
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 6722186
• Report Number: 3006260740-2017-01069
• Device Sequence Number: 10983304
• Product Code: LFJ
• UDI-Device Identifier: 00801741012426
• UDI-Public: (01)00801741012426
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K871488
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Reporter Type: Manufacturer
• Report Source: foreign,health professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 07/18/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 06/28/2020
• Device Model Number: 5533690
• Device Catalogue Number: 5533690
• Device Lot Number: REZG0389
• Was Device Available for Evaluation?: No
• Event Location: Hospital
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/18/2017
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1