MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY SL 135CM; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number N/A

Device Problem Material Discolored (1170)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 07/04/2021

Event Type  malfunction  

Manufacturer Narrative

The following were reviewed as part of this investigation: patient severity, trend analysis, applicable previous investigation(s), sample (if available), and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of discolored extension tubing was confirmed; however, the root cause was not identified.The product returned for evaluation was one 4fr s/l powerpicc solo catheter.Usage residues were observed throughout the sample.The extension tubing markings were completely worn and multiple kink impressions were observed along its length.The extension tubing appeared to be discolored along most of its length.The tubing appeared darker than that of a similar non-complainant device.Microscopic inspection of the sample confirmed discoloration of the extension tubing.The tubing was bisected longitudinally and the inside surface was examined.The discoloration was observed throughout the tubing material, but appeared to be more extensive on the outside surface.The material safety data sheet (msds) for arsenic trioxide was reviewed.Polyurethane was not included in the list of incompatible materials.While discoloration of the extension tubing was observed, the source of the discoloration could not be identified.The more extensive discoloration on the outside surface suggested that the source of the discoloration may have been introduced from the outside.Potential contributing factors include cleaning agents used to maintain the catheter/insertion site.A lot history review (lhr) of reew1954 showed no other similar product complaint(s) from this lot number.

Event Description

It was reported via ms&s "what could cause the powerpicc line to turn black? have you heard of a picc line doing this with an arsenic trioxide infusion? powerpicc line placed 6 months ago.Patient receiving arsenic trioxide through powerpicc line.Powerpicc line turning black from hub to wings.Patient arrived at the facility 1 month ago with discolored(black) picc.Nurse stated they spoke with other oncology nurses who have infused arsenic trioxide with power piccs in the past with no issues.The pharmacist also contacted the drug manufacturer and stated there are no contraindications.Patient scheduled to have powerpicc exchanged.Facility requesting a product return kit as soon as possible.Nurse states she will check the chart for a ref # and lot# and call back." additional info.Received 07/13/2021: what type of catheter securement was utilized? during her stay at facility, we utilized statlock.Patient admitted (b)(6) 2021.Date of occurrence: first documented (b)(6) 2021.Patient states it was this color for ¿many months¿.Staff all thought it was supposed to look that way until seen by myself on (b)(6) 2021.What they're being treated for: acute promyelocytic leukemia.Concomitant therapy: outside records indicate she received cytarabine, gemtuzumab and idarubicin at geisinger.She also received vancomycin, cefepime, cefazolin and gentamycin as well as magnesium, benadryl, and compazine.Does the patient have an infectious disease?: no.Ms&s response "response informed we do not have any testing with arsenic trioxide in powerpicc lines.Suggested she contact the drug manufacturer for infusion recommendations and catheter compatibility.We recommend the picc line be replaced with a new line that is compatible with the drug manufacture guidelines." on (b)(6) 2021, patient received 3 doses of alteplase during her stay.On (b)(6) 2021, the returned sample exhibited multiple kink impressions.

• Brand Name: POWERPICC SOLO CATHETER 4F RADIOLOGY BASIC TRAY SL 135CM
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 12550883
• MDR Text Key: 274003995
• Report Number: 3006260740-2021-04047
• Device Sequence Number: 1
• Product Code: LJS
• UDI-Device Identifier: 00801741027758
• UDI-Public: (01)00801741027758
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K072230
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3194135
• Device Lot Number: REEW1954
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/21/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/01/2020
• 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
• Patient Age: 26 YR
• Patient Weight: 200