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

Model Number	N/A
Medical Device Problem Code	Difficult to Remove (1528)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/21/2025
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the stylet in the picc would not unscrew so they could take it out.The event resulted in needing to over the wire exchange for a new midline for the patient.No other information was 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 device has not been received by the manufacturer for evaluation.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.
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 the inability to remove a t-lock extension set from a catheter luer is confirmed, but the exact cause could not be determined.One 4 fr s/l powermidline with its t-lock assembly was returned for evaluation.An initial visual observation of the returned catheter revealed little blood residues along the device.The stylet was not returned with the device.A functional test of attempting to remove tapered region of the t-lock extension set from the luer of the catheter revealed the t-lock extension set could not be easily removed from the catheter.Vice grips and pliers were used to remove the t-lock extension set tapered region from the catheter luer.The threads of the t-lock assembly were observed to screw and unscrew from the device with ease during the process of removing the t-lock extension set from the catheter luer.A microscopic observation revealed nothing remarkable along the inside of the luer.The luer of the catheter was measured using a luer taper gauge at a force of 5 n to reveal the luer of the catheter was within iso specifications.The tapered region of the t-lock extension set was measured using a luer taper gauge and was determined to be within iso specifications.Potential causes of this failure may include excessive force applied during assembly of the product, addition of adhesive material or chemicals with adhering properties, exposure to excessive heat causing the device material to expand, or other unknown factors.The exact cause of this failure could not ultimately be determined.This complaint will be recorded for future trending and monitoring purposes.

• 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: becky garcia ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 22298646
• Report Number: 3006260740-2025-04102
• Device Sequence Number: 8629067
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761(11)250212(17)260630(10)REKN0597
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• 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): 08/20/2025

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: 06/30/2026
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REKN0597
• 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: 05/29/2025
• Supplement Date Received by Manufacturer: 08/20/2025
• Initial Report FDA Received Date: 06/20/2025
• Supplement Report FDA Received Date: 08/26/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2025
• 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