MAUDE Adverse Event Report: BARD REYNOSA S.A. DE C.V. -9617592 POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F; CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5605150
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
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.A lot history review (lhr) of recs3172 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (recs3172) have been reported from the same facility.
Event or Problem Description
The facility reported that about a month and a half ago, air was discovered in the arterial leg of the catheter.It was stated they did not know the cause and did not investigate the catheter.(b)(6) 2018- it was stated that the catheters were sutured in.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER FULL PROCEDURE TRAY 13 F
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas ; MX
• MDR Report Key: 7857220
• Report Number: 3006260740-2018-02402
• Device Sequence Number: 11192457
• Product Code: NIE
• UDI-Device Identifier: 00801741086953
• UDI-Public: (01)00801741086953
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K133456
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,user f
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/07/2018

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: 5605150
• Device Catalogue Number: 5605150
• Device Lot Number: RECS3172
• 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: 09/07/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1