MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER WITH MICROEZ; 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	Unspecified Infection (1930)
Date of Event	05/18/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 will evaluate.Results are expected soon.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
Event or Problem Description
It was reported "picc that was found to be leaking at the purple hub." add info rcvd 06/06/2022: vast called to discontinue patient's picc due to line infection.Patient states that it has been leaking from the purple lumen at the hub for a few days.Patient states that she did verbalize this to nursing staff.I did see that it was leaking between the purple lumen and the cap at the time of removal.What type of catheter securement was utilized? unknown.Was the product used on a patient? yes.Was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome: there was no harm documented, but they did list the failure as ¿temp harm, requiring initial or prolonged hospitalization¿.Report also states: if a patient or staff reports/suspects a line is leaking then vast should be notified for further assessment.The line could be defective and/or source of infection.
Event or Problem Description
It was reported "picc that was found to be leaking at the purple hub." add info rcvd (b)(6) 2022: vast called to discontinue patient's picc due to line infection.Patient states that it has been leaking from the purple lumen at the hub for a few days.Patient states that she did verbalize this to nursing staff.I did see that it was leaking between the purple lumen and the cap at the time of removal.What type of catheter securement was utilized? unknown.Was the product used on a patient? yes.Was there any patient harm reported? if yes, please describe the harm, how it was treated and the outcome: there was no harm documented, but they did list the failure as ¿temp harm, requiring initial or prolonged hospitalization¿.Report also states: if a patient or staff reports/suspects a line is leaking then vast should be notified for further assessment.The line could be defective and/or source of infection.
Additional Manufacturer Narrative
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 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 a leaking catheter was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 4fr s/l powerpicc provena.Usage residues were observed throughout the sample.Microscopic inspection of the sample did not reveal any evidence of current or previous leakage.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration with no observed leaks.No leaks were observed during sustained (>15 seconds) pressurization.No deficiencies were discovered during evaluation of the returned sample.Consequently this complaint is unconfirmed at this time.

• Brand Name: POWERPICC 5F DUAL-LUMEN POLYURETHANE CATHETER WITH MICROEZ
• 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: kelsey erickson ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 14735183
• Report Number: 3006260740-2022-02334
• Device Sequence Number: 5800226
• Product Code: LJS
• UDI-Device Identifier: 00801741000423
• UDI-Public: (01)00801741000423
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K051672
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/06/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: 3275108
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/13/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 05/25/2022
• Supplement Date Received by Manufacturer: 07/06/2022
• Initial Report FDA Received Date: 06/17/2022
• Supplement Report FDA Received Date: 07/15/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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: Required Intervention
• Patient Age: 40 YR
• Patient Sex: Female