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

Model Number	N/A
Medical Device Problem Code	Material Deformation (2976)
Health Effect - Clinical Code	Hematoma (1884)
Date of Event	05/28/2025
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 it will be evaluated.A supplemental will be submitted with evaluation results.
Event or Problem Description
It was reported by the customer the grey part of the microintroducer was bent and nurse could not fully get into patient.Additional information received 03 june 2025: it was reported "during a routine picc line placement in the upper left arm, the procedure proceeded normally until the introduction of the peel-away introducer.After making a standard small skin incision at the guidewire entry site, i attempted to advance the introducer over the guidewire and through the superficial tissue layers.Unexpected resistance was encountered.Upon withdrawal of the introducer, i observed that the gray outer component of the device was visibly folded and torn, compromising its structural integrity.This occurred despite the use of standard technique and appropriate insertion force.Following removal, a spherical hematoma approximately the size of a silver dollar developed under the skin, along with active bleeding at the entry site.A second triple lumen picc kit was opened, and the introducer from that kit advanced without complication through the skin and into the selected vessel.Despite successful advancement of the second introducer, the overall picc attempt was ultimately discontinued due to resistance encountered in the patient¿s shoulder, unrelated to the introducer malfunction.Pressure was held at the site, and a non-compressive dressing was applied.The hematoma had significantly subsided by the time the dressing was placed.".
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 4.5 fr microintroducer was returned for evaluation.An initial visual observation revealed use residue on the sample.The dilator shaft was observed to be slightly curved, and the sheath tip was observed to be damaged.A microscopic observation revealed buckling and plastic deformation at the tip of the sheath.The observed damage can occur due to a steep insertion angle, inadequate skin nick, and/or forceful insertion against resistance.This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: POWERPICC PROVENA THICK TAPER, 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: 22309640
• Report Number: 3006260740-2025-04179
• Device Sequence Number: 8052747
• Product Code: LJS
• UDI-Device Identifier: 00801741154867
• UDI-Public: (01)00801741154867(11)250311(17)260228(10)REJZ1365
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K053501
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/29/2025

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: 02/28/2026
• Device Model Number: N/A
• Device Catalogue Number: S1385108D2
• Device Lot Number: REJZ1365
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 06/23/2025
• Supplement Report FDA Received Date: 08/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/11/2025
• 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: Other
• Patient Sex: Unknown