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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2024
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 manufacturer has received the sample and will evaluate.Results are expected soon.
Event or Problem Description
It was reported by customer that the picc wire got stuck after insertion.When removed noticed then the tip of the wire had a knot in it.Anesthesia used a picc line and it ended up with a knot in it.She used another one and it was fine.It was a seasoned anesthesia person and she said had never seen it.Provider said she inserted the wire through the needle, and it wouldn't thread into the vein so she tried to remove it and it wouldn't come out.It was like stuck in there.So they asked for an xray and it was in the subcutaneous tissue and at that point in time she made a wider excision in the skin and then applied some significant traction and was able to remove.Noticed then the tip of the wire had a knot in it.She only had made one attempt with that one, then got a new kit, switched arms and was able to get it in.
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 knot in the guidewire is confirmed and was determined to be use-related.One 21 ga introducer needle and one 0.018 in.Nitinol guidewire was returned for evaluation.An initial visual observation revealed blood use residues throughout the returned guidewire and introducer needle.A knot was observed at the distal end of the guidewire.The needle was observed to have a slight bend along the needle shaft.The needle safety mechanism was advanced over the needle tip.A microscopic observation revealed misaligned coils along the distal end of the guidewire up to the knot in the guidewire at the distal tip of the guidewire.The distal weld tip was observed to be attached to the end of the guidewire.Blood was observed along the knot in the guidewire.The needle bevel was observed to have slight deformation from the guidewire pulling against the bevel.The knot in the distal end of the guidewire was likely caused by repeated advancement and retraction of the guidewire against resistance, combined with a twisting motion.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported by customer that the picc wire got stuck after insertion.When removed noticed then the tip of the wire had a knot in it.Anesthesia used a picc line and it ended up with a knot in it.She used another one and it was fine.It was a seasoned anesthesia person and she said had never seen it.Provider said she inserted the wire through the needle, and it wouldn't thread into the vein so she tried to remove it and it wouldn't come out.It was like stuck in there.So they asked for an xray and it was in the subcutaneous tissue and at that point in time she made a wider excision in the skin and then applied some significant traction and was able to remove.Noticed then the tip of the wire had a knot in it.She only had made one attempt with that one, then got a new kit, switched arms and was able to get it in.

• Brand Name: POWERPICC SV CATHETER 4F MAXIMAL BARRIER 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19056309
• Report Number: 3006260740-2024-01520
• Device Sequence Number: 15461067
• Product Code: LJS
• UDI-Device Identifier: 00801741027833
• UDI-Public: (01)00801741027833
• Combination Product (Y/N): N
• Initial Reporter State: IA
• 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): 06/12/2024

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: 06/30/2024
• Device Model Number: N/A
• Device Catalogue Number: 3274108D
• Device Lot Number: REHN2431
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/25/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2024
• Supplement Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 04/05/2024
• Supplement Report FDA Received Date: 06/22/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2023
• 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: 60 YR
• Patient Sex: Female