MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SV CATHETER 4F FULL TRAY (DUAL-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported vascular access team called to patient's bedside due to leaking 4fr double lumen picc line.Nurse was told by mother of patient that the "white port" of the double lument picc was leaking since last night (04/15) at approximately 8:00pm after the patient came back from his mri.Mother of patient stated that the night nurses were changing the patient's dressing and flushed the white port and it had started leaking.Nurse flushed the white port of the picc line and right away there was leaking from the hub of the catheter, where the picc line meetings with the hard white plastic of the hub.Bedside nurse was notified that the line needed to be changed and orders were placed.Picc line was replaced with a single lumen 3fr picc line.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The manufacturer has received the sample and is pending evaluation.Results are expected soon.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The product returned for evaluation was a 4fr dual lumen powerpicc sv with two needleless injection caps.The catheter exhibited a shared break at the 8cm depth marking and was terminated at the 25cm depth marking.Microscopic inspection of the break at the 8cm depth marking revealed an uneven, granular surface with a region of increased luster.The catheter shaft exhibited a deformed and a partial elliptical shape.Microscopic inspection of the distal end of the catheter revealed a surface that was glossy and striated, consistent of a sharp instrument cut.A significant amount of biological use residue was lodged in the distal end of the catheter.The elliptical cross section and uneven break were consistent with damage caused by compression of the indwelling catheter shaft which suggests that the material ultimately failed due to pulling stress likely during catheter removal.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported vascular access team called to patient's bedside due to leaking 4fr double lumen picc line.Nurse was told by mother of patient that the "white port" of the double lument picc was leaking since last night ((b)(6)) at approximately 8:00pm after the patient came back from his mri.Mother of patient stated that the night nurses were changing the patient's dressing and flushed the white port and it had started leaking.Nurse flushed the white port of the picc line and right away there was leaking from the hub of the catheter, where the picc line meetings with the hard white plastic of the hub.Bedside nurse was notified that the line needed to be changed and orders were placed.Picc line was replaced with a single lumen 3fr picc line.
Additional Manufacturer Narrative
H11: section a through f - the information provided by bd 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 bd.The product returned for evaluation was a 4fr dual lumen powerpicc sv with two needleless injection caps.The catheter exhibited a shared break at the 8cm depth marking and was terminated at the 25cm depth marking.Microscopic inspection of the break at the 8cm depth marking revealed an uneven, granular surface with a region of increased luster.The catheter shaft exhibited a deformed and a partial elliptical shape.Microscopic inspection of the distal end of the catheter revealed a surface that was glossy and striated, consistent of a sharp instrument cut.A significant amount of biological use residue was lodged in the distal end of the catheter.The elliptical cross section and uneven break were consistent with damage caused by compression of the indwelling catheter shaft which suggests that the material ultimately failed due to pulling stress likely during catheter removal.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SV CATHETER 4F FULL TRAY (DUAL-LUMEN)
• Common Device Name: 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: 19354782
• Report Number: 3006260740-2024-02471
• Device Sequence Number: 18019990
• Product Code: LJS
• UDI-Device Identifier: 00801741027826
• UDI-Public: (01)00801741027826
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K102159
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/03/2024

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 Expiration Date: 04/30/2025
• Device Model Number: N/A
• Device Catalogue Number: 3274108
• Device Lot Number: REHY1272
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/26/2024
• Supplement Date Received by Manufacturer: 07/03/2024
• Initial Report FDA Received Date: 05/20/2024
• Supplement Report FDA Received Date: 07/10/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/01/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown