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

Model Number	N/A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Hypersensitivity/Allergic reaction (1907); Numbness (2415); Movement Disorder (4412)
Date of Event	06/18/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported, at 1302, 4 fr double lumen peripherally inserted central catheter inserted to the left vein per hospital protocol.1330 - received call from rn stating that patient is complaining of numbness in left arm and having trouble opening hand.States mild swelling noted at picc site.1345 - picc team arrived to patient's room.Patient sitting up in bed holding left arm, states it's numb and painful and his hand feels cold.Radial and brachial pulse present dressing cdi mild swelling noted at insertion site.1350 - left arm picc line removed tip of catheter intact due to complaints of discomfort.Measurement matching pre insertion measurement 48 cm.Mild bleeding noted at insertion site pressure held over site and 4x4 dressing applied.Patient verbalizes feeling is starting to come back in hand says feeling warmer but complains of discomfort in left elbow.Due to low platelet count less than 35.Will re-evaluate first thing in morning before attempting replacing picc in right arm.1546 - left arm assessed.Patient states feeling is back in hand and arm feels much better.No swelling or bleeding noted.Will place picc in right arm first thing in the morning.(b)(6) - picc line placed in right arm successful with no complaints and was discharged with picc line.Additional information provided: patient was not evaluated for a blood clot due to relief of all symptoms when line was pulled.Other then picc removal, no other intervention was needed to treat the patient's symptoms.No damage to the catheter was noted.All symptoms resolved once it was removed.No symptoms of nerve damage after removal.We use the 45% or less and smallest catheter available.Our machine does not scan for the exact vein to catheter ratio.
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.Each event reported to bd is evaluated and investigated in accordance with our complaint investigation procedures.The investigation process includes, but is not limited to, evaluation of the event details provided by the complaint facility, a review of complaint history, manufacturing records and risk document where applicable, and an evaluation of the subject device when available to identify potential contributing factors.The device has not been returned to the manufacturer for evaluation, as the device was discarded after the event occurred.

• Brand Name: POWERPICC PROVENA
• 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 23072298
• Report Number: 3006260740-2025-06999
• Device Sequence Number: 15951762
• Product Code: LJS
• UDI-Device Identifier: 00801741155000
• UDI-Public: (01)00801741155000(11)240415(17)260531(10)REKP1330
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K180548
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/01/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/31/2026
• Device Model Number: N/A
• Device Catalogue Number: S1294108D3
• Device Lot Number: REKP1330
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/28/2025
• Initial Report FDA Received Date: 09/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/15/2025
• 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