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

Model Number	N/A
Medical Device Problem Code	Product Quality Problem (1506)
Health Effect - Clinical Codes	Air Embolism (1697); Muscle Weakness/Atrophy (1967)
Date of Event	01/11/2026
Type of Reportable Event	Serious Injury
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 patient's left basilic vein was inserted with powerpicc solo at left svc by radiologist on (b)(6) 2026.Embolism was found in patient after few days.On (b)(6) 2026, surgeon doctor removed the picc.After removal of the picc, the removed picc was shown intact with the remaining tip.Hospital suspected that the air was gone in though valve in the powerpicc solo.No further information was provided.
Event or Problem Description
Additional information: air embolism was treated with hyperbaric oxygen therapy.It is unknown how much air embolized.Patient reported right-side weakness to the nurse.Nurse assessed the patient, gcs was e4m5v6, limb power of right side 2/5, left side 4/5, bilateral pupil size 3mm, reactive to light.Blood pressure: 101/72mmhg, pulse: 89/minutes, spo2: 94% in room air, temperature: 36.6.Patient's status post-treatment was requested but not 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.
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 leaking valve was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 5fr dl powerpicc solo catheter.The unit was functionally tested by flushing the luer with water using a 12 ml luer lock syringe.During testing, no leaks were identified.The solo valve was separately tested by infusing the catheter with water and suspending the catheter upside down to observe if the solo valve leaked; however, no leaks were identified.The catheter was microscopically inspected but no remarkable features were observed.Based on the available evidence, the reported failure could not be confirmed.This complaint will be recorded for future trending and monitoring purposes.
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 leaking valve was unconfirmed because the problem could not be reproduced.The product returned for evaluation was one 5fr dl powerpicc solo catheter.The unit was functionally tested by flushing each luer with water using a 12 ml luer lock syringe.During testing, no leaks were identified.Both solo valves were separately tested by infusing the catheter with water and suspending the catheter upside down to observe if either of the solo valves leaked; however, no leaks were identified.The catheter was microscopically inspected but no remarkable features were observed.Based on the available evidence, the reported failure could not be confirmed.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC SOLO2
• 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: becky sparks ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 24378841
• Report Number: 3006260740-2026-00927
• Device Sequence Number: 16016880
• Product Code: LJS
• UDI-Device Identifier: 00801741028106
• UDI-Public: (01)00801741028106(11)250505(17)260930(10)REKQ1507
• 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 Implanted Year: 2026
• Device Explanted Year: 2026
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date (Section B): 06/01/2026

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 Expiration Date: 09/30/2026
• Device Model Number: N/A
• Device Catalogue Number: 3295135
• Device Lot Number: REKQ1507
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/03/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2026
• Supplement Date Received by Manufacturer: 02/23/2026; 04/13/2026; 06/01/2026
• Initial Report FDA Received Date: 02/18/2026
• Supplement Report FDA Received Date: 02/25/2026; 04/16/2026; 06/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2025
• 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 Sex: Unknown