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

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	01/06/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer, ¿vein was accessed easily in the peds or and wire passed very smoothly.Prior to threading the introducer over the wire, i checked to make sure it was in the locked position.When advancing the introducer through the skin, it buckled and the stiff portion within the peel-away-sheath slid back.I removed it from the wire and attempted to place it back into the locked position.However, when i went to put it back into the locked position, it continued to spin.It looked like the little plastic peg had snapped off making it unable to be locked into place.It just freely spun around.I feel like the plastic was very weak and allowed the introducer to slip back through the sheath.¿ additional information: it was reported by the customer, ¿this ultimately did not affect the patient outcome as we were able to successfully access an adjacent vein and place the picc.However, we attempted to advance a new introducer over the original wire, but the vein was no longer viable under ultrasound.This did necessitate re-accessing.To my knowledge, no changes to clinical signs or health impacts were observed.There was no adverse event or injury to the patient or healthcare professional.A new introducer from another kit was used.¿.
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 it will be evaluated.A supplemental will be submitted with evaluation results.
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 damaged microintroducer is confirmed and was determined to be use-related.One 3.5 fr microintroducer was returned for evaluation.An initial visual observation showed use residue on the sample.A microscopic observation revealed the tip of the sheath was buckled and plastically deformed.A small longitudinal split was observed on one edge of the sheath tip.The shape, location, and extent of the observed damage suggests the sheath encountered resistance during insertion, possibly due to the insertion angle, inadequate skin nick, or contact with a hard surface such as scar tissue.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA, 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: kayla bevins ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 21305167
• Report Number: 3006260740-2025-00320
• Device Sequence Number: 8903559
• Product Code: LJS
• UDI-Device Identifier: 00801741134104
• UDI-Public: (01)00801741134104(11)241002(17)251130(10)REJV3897
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K162443
• 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): 04/14/2025

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: 11/30/2025
• Device Model Number: N/A
• Device Catalogue Number: S1173108PD
• Device Lot Number: REJV3897
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/07/2025
• Supplement Date Received by Manufacturer: 04/14/2025
• Initial Report FDA Received Date: 02/04/2025
• Supplement Report FDA Received Date: 04/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/01/2024
• 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