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

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/31/2022
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the powerpicc solo catheter was placed around two weeks before the event occurred (31/8).The catheter was found leakage from the hub when the needless connector was removed.It was only used for drug infusion by pump and could be functioned properly when the needless connector was on.It was removed at the end of treatment (9/9).Patient status/ intervention: no intervention.
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 is pending evaluation.Results are expected soon.A lot history review (lhr) of refw1286 showed no other similar product complaint(s) from this lot number.
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 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 valve failure was confirmed.The product returned for evaluation was one 4fr s/l powerpicc solo catheter.Usage residues were observed throughout the sample.A needleless injection cap was attached to the luer adapter and a slide clamp had been placed on the extension tubing.An attempt to infuse water through the sample using a 12ml syringe revealed the sample to be patent to infusion and aspiration.The sample was charged with water and held vertically from the distal end.Water leaked through the solo valve.Microscopic inspection of the valve revealed biological residue adhered to the outside surface.Following valve removal, microscopic inspection of the inside surface revealed coagulated blood products adhered to the valve.Blood products were visible caught within the valve slit, preventing complete valve closure.The valve did not function as intended during functional testing.It appeared that biological residue within the valve housing prevented valve closure, resulting in the observed functional failure.It appeared that catheter maintenance/lock off procedures may have contributed.H3 other text : evaluation findings are in section h11.
Event or Problem Description
It was reported that the powerpicc solo catheter was placed around two weeks before the event occurred (31/8).The catheter was found leakage from the hub when the needless connector was removed.It was only used for drug infusion by pump and could be functioned properly when the needless connector was on.It was removed at the end of treatment (9/9).Patient status/ intervention: no intervention.

• Brand Name: POWERPICC SOLO CATHETER 5F RADIOLOGY BASIC TRAY (135 CM)
• 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: 15506463
• Report Number: 3006260740-2022-03828
• Device Sequence Number: 5224580
• Product Code: LJS
• UDI-Device Identifier: 00801741027802
• UDI-Public: (01)00801741027802
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K072230
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Explanted Year: 2022
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/01/2022

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: 02/28/2023
• Device Model Number: N/A
• Device Catalogue Number: 3195335
• Device Lot Number: REFW1286
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/26/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 09/09/2022
• Supplement Date Received by Manufacturer: 11/01/2022
• Initial Report FDA Received Date: 09/29/2022
• Supplement Report FDA Received Date: 11/04/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2021
• 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