MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 POWERMIDLINE; MIDLINE CATHETER

Model Number	N/A
Medical Device Problem Codes	Fluid/Blood Leak (1250); Material Deformation (2976)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/23/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that there is a crack at the white power midline entrance as the picc enters it.Staff said when attempting to place the site was leaking at the arm when attempting to flush.No further details available or 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.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.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.
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 leak from detached extension tubing is confirmed and was determined to be related to the manufacture of the product.One 4 fr s/l powermidline catheter was returned for evaluation.An initial visual observation of the returned catheter showed little use residues on the device.The extension tubing was observed to be partially detached from the molded joint.No excess extension tubing was observed inside the molded joint.A microscopic observation revealed the fracture surface of the extension tubing to have striations from a bladed instrument.The fracture surface appeared shiny and rounded.The molded suture wings were cut longitudinally to measure the molding space for the extension tubing along the molded suture wings.The space the extension tubing is molded with the suture wings should be.300 in.In length; however, this space on the returned sample was measured to be approximately.0176 in.In length.The root cause of this failure was determined to be caused by insufficient molding of the extension tubing and is therefore related to the manufacture of the product.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
Additional information: device was removed and replaced by a new one.

• Brand Name: POWERMIDLINE
• Common Device Name: MIDLINE CATHETER
• 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 ; 8015950700
• MDR Report Key: 23768966
• Report Number: 3006260740-2025-09512
• Device Sequence Number: 21473411
• Product Code: PND
• UDI-Device Identifier: 00801741200809
• UDI-Public: (01)00801741200809(11)250808(17)260731(10)REKT0229
• Combination Product (Y/N): Y
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• 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): 03/16/2026

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 Expiration Date: 07/31/2026
• Device Model Number: N/A
• Device Catalogue Number: CK000912A
• Device Lot Number: REKT0229
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/24/2025
• Supplement Date Received by Manufacturer: 03/16/2026
• Initial Report FDA Received Date: 12/10/2025
• Supplement Report FDA Received Date: 03/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 08/08/2025
• 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