MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC CATHETER 4F MAXIMAL BARRIER TRAY SL (55CM) W/MICROINTRODUCER; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/10/2023
Type of Reportable Event	Malfunction
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 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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by the customer that they have a picc that have needed replaced, as it was leaking thru pinholes in the catheter line.Patient has picc for daptomycin iv.Received call from hh rn stating line will not flush, unable to infuse iv abx( b)(6)2023.Patient came to our office for cathflo.While troubleshooting this picc prior to using cathflo, it was noted with flushing, the dressing started dripping.I removed the dressing and observed fluid coming from the insertion site while flushing.I redressed the line and sent patient to facility for new picc placement.Upon removal, line was observed to have a hole at the 2 cm mark.No harm came to the patient, except they missed 2 doses of iv abx.
Additional Manufacturer Narrative
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.Based on a review of this information, the following was concluded: the complaint of a leaking powerpicc is unconfirmed because the problem could not be reproduced.One 4 fr s/l powerpicc was returned for evaluation.An initial visual observation revealed use residues throughout the returned powerpicc catheter.A functional test of attempting to pressurize the catheter using water and a 12 ml syringe revealed no leaks throughout the catheter.The catheter was patent to infusion after pressurization attempts with no observed leaks.A microscopic observation revealed nothing remarkable throughout the returned catheter.Because leaking could not be found during a functional test of the returned catheter, the complaint of a leaking catheter is unconfirmed.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by the customer that they have a picc that have needed replaced, as it was leaking thru pinholes in the catheter line.Patient has picc for daptomycin iv.Received call from hh rn stating line will not flush, unable to infuse iv abx on (b)(6) 2023.Patient came to our office for cathflo.While troubleshooting this picc prior to using cathflo, it was noted with flushing, the dressing started dripping.I removed the dressing and observed fluid coming from the insertion site while flushing.I redressed the line and sent patient to facility for new picc placement.Upon removal, line was observed to have a hole at the 2 cm mark.No harm came to the patient, except they missed 2 doses of iv abx.

• Brand Name: POWERPICC CATHETER 4F MAXIMAL BARRIER TRAY SL (55CM) W/MICROINTRODUCER
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18012345
• Report Number: 3006260740-2023-04863
• Device Sequence Number: 20700320
• Product Code: LJS
• UDI-Device Identifier: 00801741028731
• UDI-Public: (01)00801741028731
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K070996
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/17/2024

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: 07/31/2024
• Device Model Number: N/A
• Device Catalogue Number: CK000060
• Device Lot Number: REHP1723
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/23/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/10/2023
• Supplement Date Received by Manufacturer: 01/17/2024
• Initial Report FDA Received Date: 10/26/2023
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2023
• 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 Age: 63 YR
• Patient Sex: Female