MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Failure to Infuse (2340)

Patient Problem Pain (1994)

Event Date 01/11/2023

Event Type  malfunction  

Event Description

It was reported by the customer, 'patient uses powerpicc 2 lumens for chemotherapy and would like a maintenance manual.What i need to know is whether there is an indication to unblock the catheter that was already installed and was being used for chemotherapy and that was blocked for both aspiration and infusion.' (b)(6) 2023 additional information provided the power picc was placed in (b)(6) 2022 on patient's msd.The first aspiration and flush were done 3 days after placement and then every week.From the first maintenance i realized that there was difficulty in aspiration, sometimes it was blocked for aspiration.The nurses performed a small infusion of saline solution and the aspiration started again.I started to realize that during the flush the patient complained of pain and discomfort in his arm.Sometimes more, sometimes less.In december, i found instructions on the bd website to replace the catheter in case of difficulty in suctioning.I questioned the medical team about the difficulties encountered in aspiration and was confronted with the nursing team who denied any difficulty, but obviously it was not normal to pull the plunger of the syringe all the way back and not see blood.Then, on january 6, the catheter was completely and definitively blocked.The nursing team called the catheter specialist doctor who determined that they proceed with a maneuver to try to unblock it using a medication and a standard operating procedure that was presented to me.I questioned the use of this procedure and was convinced that i should try to unlock it, as the procedure invoked a vast bibliography.The procedure was performed and still did not unlock.Withdrawal proceeded.A new catheter is scheduled for placement on the next wednesday, the 18th.Four bevacizumab infusions were performed during this period.The infusion difficulty resulted in pain and it is very difficult to convince the patient to continue the treatment.There was no difficulty in the removal or need for exams.The catheter was removed and should be replaced next (b)(6).For the implantation of a new catheter, it will take place in a surgical center and hospitalization for one day.Additional information received (b)(6) 2023: the installation of a new catheter was postponed without forecast.

Manufacturer Narrative

The date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.A batch history review (bhr) of reez2401 showed no other similar product complaint(s) from this lot number.

• Brand Name: POWERPICC 5F NURSE BASIC TRAY WITH MICROINTRODUCER (DUAL-LUMEN)
• Type of Device: CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
• Manufacturer (Section D): C.R. BARD, INC. (BASD) -3006260740; 605 north 5600 west; salt lake city 84116
• Manufacturer (Section G): BARD REYNOSA S.A. DE C.V. -9617592; blvd. montebello #1; parque industrial colonial; reynosa, tamaulipas 88780 ; MX 88780
• Manufacturer Contact: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16285937
• MDR Text Key: 309398906
• Report Number: 3006260740-2023-00323
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027918
• UDI-Public: (01)00801741027918
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K051672
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 01/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: N/A
• Device Catalogue Number: 3275118
• Device Lot Number: REEZ2401
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other