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

Model Number	N/A
Medical Device Problem Code	Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/12/2023
Type of Reportable Event	Malfunction
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.H3 other text : device not returned for evaluation.
Event or Problem Description
It was reported that the midline was placed with no incident, midline provided good blood return when assessed but then when flushed began to spray saline around the suture wings where they met the catheter.Midline was removed and replaced.
Event or Problem Description
It was reported that the midline was placed with no incident, midline provided good blood return when assessed but then when flushed began to spray saline around the suture wings where they met the catheter.Midline was removed and replaced.Additional information received may 1, 2023: patient admitted to the icu due to respiratory failure, on multiple drips, connected to a ventilator, very difficult venous access.Event did not involve an urgent/life threatening medical situation.Event did not interrupt treatment; clinician was able to fix the problem immediately without interrupting patient care or patient treatment.Planned medications to be infused, typical iv fluids for hydration, iv antibiotics, and iv sedatives.There was no patient harm, injury, or negative outcome as the problem was corrected immediately.
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.

• Brand Name: 4FR DL POWERMIDLINE FULL KIT
• 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: johanna de oliveira ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 16856094
• Report Number: 3006260740-2023-01657
• Device Sequence Number: 12455281
• Product Code: PND
• UDI-Device Identifier: 00801741129278
• UDI-Public: (01)00801741129278
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: K162900
• 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): 05/04/2023

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: 11/30/2023
• Device Model Number: N/A
• Device Catalogue Number: P4254108
• Device Lot Number: REGV1298
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 04/12/2023
• Supplement Date Received by Manufacturer: 05/01/2023
• Initial Report FDA Received Date: 05/02/2023
• Supplement Report FDA Received Date: 05/05/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• 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: 34 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic