MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DL) (135CM GUIDEWIRE); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS

Model Number	N/A
Medical Device Problem Code	Failure to Infuse (2340)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/14/2023
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 device has not been returned to the manufacturer for evaluation.H3: device not returned.
Event or Problem Description
It was reported by the customer picc line placed april 10th issues developed where picc line port could not be used, unable to flush and aspirate from red port.Altaplase was put in line but it did not clear the line.No apparent harm, inconvenient.Additional information 09-may-2023.The piccs were being used for iv therapy including fluid, antibiotics and nutrition.The staff were trying to flush the piccs as per protocol.We attempted to deal with the piccs using alteplase, antibiotics and nutrition held.Caused a delay in antibiotic therapy and nutrition.There were no further surgeries, tests except for picc lines needing to be rethreaded and/or replaced.
Event or Problem Description
It was reported by the customer picc line placed april 10th issues developed where picc line port could not be used, unable to flush and aspirate from red port.Altaplase was put in line but it did not clear the line.No apparent harm, inconvenient.Additional information 09-may-2023 : the piccs were being used for iv therapy including fluid, antibiotics and nutrition.The staff were trying to flush the piccs as per protocol.We attempted to deal with the piccs using alteplase, antibiotics and nutrition held.Caused a delay in antibiotic therapy and nutrition.There were no further surgeries, tests except for picc lines needing to be rethreaded and/or replaced.
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 complaint of a catheter unable to infuse is not confirmed because the issue could not be reproduced.One 5 fr d/l powerpicc solo was returned for evaluation.An initial visual observation showed abundant blood use residues throughout the returned catheter, and a significant amount of blood was observed in the red lumen extension tubing.A functional test of attempting to infuse water into each lumen using a 12 ml syringe revealed each lumen to be patent to infusion without resistance.An attempt to aspirate water through each lumen using a 12 ml syringe was successful without resistance, manipulation of the device, or difficulty.A microscopic observation revealed nothing remarkable along the returned catheter.Because the catheter was patent to infusion and aspiration without resistance, the complaint of a catheter having difficulty with infusion and aspiration could not be confirmed.Potential causes of difficulty aspirating or infusing may include placement techniques or environmental factors contributing to the devices suspected failure.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (DL) (135CM GUIDEWIRE)
• 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: 16942700
• Report Number: 3006260740-2023-01928
• Device Sequence Number: 19658391
• Product Code: LJS
• UDI-Device Identifier: 00801741028106
• UDI-Public: (01)00801741028106
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/31/2023

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: 09/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 3295135
• Device Lot Number: REGX2131
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/02/2023
• Supplement Date Received by Manufacturer: 07/31/2023
• Initial Report FDA Received Date: 05/16/2023
• Supplement Report FDA Received Date: 08/04/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2022
• 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