MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT (13 F) (15CM) (TL); CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED

Model Number	5603150
Health Effect - Clinical Code	No Patient Involvement (2645)
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 packaging was discarded and the device remains in the patient.A lot history review (lhr) of recn1891 showed three other similar product complaint(s) from this lot number.The complaints for this lot number (recn1891) have been reported from the same (b)(4) facility.
Event or Problem Description
It has been reported that the trialysis packaging is "very frustrating to work with." the reporter states that the packages are extremely tight fitting and they don¿t peel back so the doctors have to cut the packaging to release the interior package.This also compromises the sterility because they then empty the contents out into the sterile field.It was stated the last 4 insertions have been this way for this facility.It was additionally stated that, "we literally couldn't pull the interior package out even with two people trying." no patient involvement.This report addresses the first event.

• Brand Name: POWER-TRIALYSIS SHORT-TERM STRAIGHT DIALYSIS CATHETER KIT (13 F) (15CM) (TL)
• Common Device Name: CATHETER, HEMODIALYSIS, TRIPLE LUMEN, NON-IMPLANTED
• Manufacturer (Section D): BARD ACCESS SYSTEMS; 605 n. 5600 w.; salt lake city UT 84116
• MDR Report Key: 7813919
• Report Number: 3006260740-2018-02229
• Device Sequence Number: 1176156
• Product Code: NIE
• UDI-Device Identifier: 00801741041853
• UDI-Public: (01)00801741041853
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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: Nurse
• Type of Report: Initial
• Report Date (Section B): 08/24/2018

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: 5603150
• Device Catalogue Number: 5603150
• Device Lot Number: RECN1891
• 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: 08/24/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1