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

Model Number	N/A
Medical Device Problem Codes	Material Frayed (1262); Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported via medwatch, power midline catheter had a frayed guidewire.This was noticed before the line was placed in the patient.Procedure was paused while a colleague obtained a new midline kit.When new kit arrived, new line was inspected and found to be within normal limits.Procedure completed with no further issues.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 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 product returned for evaluation was a hydrophilic stiffening stylet with a t-lock extension tube.The stylet was observed to be intact with some bends throughout the stylet.The t-lock assembly was approximately halfway down the stylet.Microscopic inspection of the stylet revealed the hydrophilic coating appeared to be peeling off of the stylet.The coating appeared to be white and flaking.Possible causes of the coating coming off of the stylet include environmental conditions and excessive manipulation of the stylet.However, other unidentified factors may have also contributed.This complaint will be recorded for future trending and monitoring purposes.
Event or Problem Description
It was reported via medwatch, power midline catheter had a frayed guidewire.This was noticed before the line was placed in the patient.Procedure was paused while a colleague obtained a new midline kit.When new kit arrived, new line was inspected and found to be within normal limits.Procedure completed with no further issues.No other information was provided.

• Brand Name: DOT,4FR 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 19939071
• Report Number: 3006260740-2024-04317
• Device Sequence Number: 4953447
• Product Code: PND
• UDI-Device Identifier: 00801741108761
• UDI-Public: (01)00801741108761(11)231108(17)250228(10)REHW2001
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K153393
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/30/2024

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: 02/28/2025
• Device Model Number: N/A
• Device Catalogue Number: P4154108D
• Device Lot Number: REHW2001
• 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: 07/15/2024
• Supplement Date Received by Manufacturer: 10/30/2024
• Initial Report FDA Received Date: 08/08/2024
• Supplement Report FDA Received Date: 11/24/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/01/2023
• 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 Age: 27 YR
• Patient Sex: Female
• Patient Ethnicity: Non Hispanic
• Patient Race: White