MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 DOT, 4 FR POWERMIDLINE; MIDLINE CATHETER

Catalog Number	P4154108D
Medical Device Problem Code	Material Frayed (1262)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported by the customer that this particular midline kit cannot pull the stiffening stylet and when she tried to pull hardly against the t lock, the stylet started to stretch and shred.Decided to place the catheter without the stylet.No other information provided at this time.Additional information provided 10/28/2024: the result of the malfunction did directly affect the patient as the needle and guidewire were in the patient when it became stuck, and they could not remove or thread after the vein was cannulated.The guidewire was placed with ease and no obvious abnormalities noted.After the introducer was inserted, the rn was not able to remove guidewire.Multiple attempts were made and after several minutes she was able to remove the guidewire and it was noted to be bent and frayed.
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 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 damaged style is confirmed.The product returned for evaluation was a t-lock assembly with stylet.The investigation findings are consistent with damage caused by excessive force in attempting to remove the stylet.The returned product sample was evaluated and the stylet was confirmed to be broken which allowed the outer coil wire to become unraveled.Microscopic examination of the fracture sites revealed the following: ¿ narrowing of the wire cross-section near the fracture site, which is a characteristic feature of a strong pull on the wire ¿ the weld tip of the wire was missing and could not be accounted for during the evaluation although it could be confirmed that the wire had become damaged, the exact root cause could not be determined from the sample.Possible contributing factures could include degradation of hydrophilic coating, failure to hydrate stylet prior to removal, the stylet kinking prior to removal, the stylet being pulled through t-lock assembly, or patient¿s anatomy or physiology (e.G.The device is placed in a tortuous path or venospasm restricts the stylet in the catheter).This complaint will be recorded for future trending and monitoring purposes.

• Brand Name: DOT, 4 FR 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: shelly gilbert ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 20631503
• Report Number: 3006260740-2024-06494
• Device Sequence Number: 20842865
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761(11)240430(17)250831(10)REJQ1229
• Combination Product (Y/N): N
• Initial Reporter State: MD
• 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): 04/17/2025

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: 08/31/2025
• Device Catalogue Number: P4154108D
• Device Lot Number: REJQ1229
• 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: 10/14/2024
• Supplement Date Received by Manufacturer: 04/16/2025
• Initial Report FDA Received Date: 11/07/2024
• Supplement Report FDA Received Date: 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/01/2024
• 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