MAUDE Adverse Event Report: C.R. Bard, Inc. (BASD) -3006260740 PowerPICC; 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	06/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the introducer has been observed to buckle during insertion.It was reported this occurred with 2 devices.This report addresses both devices.09/08/2026: during evaluation it was found that a microscopic observation revealed the longitudinal split in the sheath to have sharp fracture edges.
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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The complaint of a microintroducer sheath split is confirmed, but the root cause could not be determined.One 4.5 fr microintroducer sheath was returned for evaluation.An initial visual observation of the returned device showed blood residues throughout the microintroducer.A longitudinal split was observed at the distal end of the sheath.Use deformation was observed at the sheath split area.A microscopic observation revealed the longitudinal split in the sheath to have sharp fracture edges, light blood residues inside the split, and evidence of the sheath fibers between the sheath split.The deformation along the distal end of the sheath split was indented and buckled.The features of the damage suggested that the sheath may have been damaged due to excessive insertion force, an inadequate skin nick, a steep insertion angle, or an abrupt transition between the sheath and dilator; however, without further inspection of a physical sample this could not be conclusively determined.Therefore, the root cause remains unknown.This complaint will be recorded for future trending and monitoring purposes.A sample was not returned for the other reported occurrence; therefore, that occurrence is inconclusive at this time.

• Brand Name: PowerPICC
• 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: yolanda thompson ; 605 north 5600 west; salt lake city 84116 ; +1(801)595-0700
• MDR Report Key: 50883629
• Report Number: 3006260740-2026-07003
• Device Sequence Number: 13450587
• Product Code: LJS
• UDI-Device Identifier: 00801741034466
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K091324
• 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
• Report Date (Section B): 09/14/2026

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 Model Number: N/A
• Device Catalogue Number: 1174118
• Device Lot Number: REKY1025
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 07/23/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/08/2026
• Initial Report FDA Received Date: 09/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/31/2025
• 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