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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/12/2023

Event Type  malfunction  

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 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 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.

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
• Type of Device: 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
• MDR Text Key: 314415195
• Report Number: 3006260740-2023-01657
• Device Sequence Number: 1
• Product Code: PND
• UDI-Device Identifier: 00801741129278
• UDI-Public: (01)00801741129278
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K162900
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 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
• Device Operator: 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
• Initial Date Manufacturer Received: 04/12/2023
• Initial Date FDA Received: 05/02/2023
• Supplement Dates Manufacturer Received: 05/01/2023
• Supplement Dates FDA Received: 05/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 34 YR
• Patient Sex: Female
• Patient Weight: 68 KG
• Patient Ethnicity: Hispanic