MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERPICC SOLO2, 3CG; PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)

Model Number	N/A
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/09/2025
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 be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
"it was reported it appeared that the wire was missing the coppery tip.No other information was provided.".
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 broken stylet was confirmed but the root cause could not be determined.The product returned for evaluation was one 4fr sl powerpicc catheter w/ 3cg stylet.The sample was returned with the stylet still inside the catheter.The tip of the stylet could be felt through the catheter and was found to be approximately 2cm from the distal end of the catheter tubing.The stylet was pulled out and inspected.Gross visual inspection found that a break was present at the distal end of the stylet on the polyimide tubing.Microscopic inspection of the break site found that half of the break site had a planar surface.Furthermore, some of the sections of the planar surface were reflective and faint striations could be identified.These features suggested that a sharp instrument may have damaged the area.The other half of the break site was dull and had an uneven surface.Given the proximity of the stylet to the tip of the catheter, it is possible that the stylet was partially cut during trimming of the catheter; however, the features observed did not provide sufficient evidence to conclusively determine this.Therefore, the root cause remains unknown.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported "our clinical specialist was doing a didactic picc class today.This was not done on a patient it was on an fake arm.We noticed it appeared that the wire was missing the coppery tip.The nurse did not feel the cut it and we could not find it anywhere.".

• Brand Name: POWERPICC SOLO2, 3CG
• Common Device Name: PERIPHERALLY INSERTED CENTRAL CATHETER (PICC)
• 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: jomil padin ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21286361
• Report Number: 3006260740-2025-00254
• Device Sequence Number: 18100444
• Product Code: LJS
• UDI-Device Identifier: 00801741154881
• UDI-Public: (01)00801741154881(11)240321(17)250731(10)REJP0630
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K072230
• 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): 05/02/2025

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: 07/31/2025
• Device Model Number: N/A
• Device Catalogue Number: 1194108D2
• Device Lot Number: REJP0630
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/09/2025
• Supplement Date Received by Manufacturer: 05/02/2025
• Initial Report FDA Received Date: 01/31/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2024
• 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