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

Model Number N/A

Device Problem Fluid/Blood Leak (1250)

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

Event Date 02/22/2024

Event Type  malfunction  

Event Description

It was reported, "for several weeks, the service has been encountering problems on the midline: leaks, lack of reflux after 2 days.Nurses found that the protective dressing (tegaderm) contained a large amount of infusion fluid at the midline insertion site.The grip lock bandage was soaked.Redid the dressing, injected saline into the catheter and observed no leakage.However, 2 hours after reconnecting the patient with his continuous iv treatment, a new liquid was stagnating under the dressing, still at the insertion site." it was reported this occurred with two devices.This report addresses the first device.

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 date of event was not provided by the complainant/reporter, the date reflected in this report is the date bd became aware of the event.The device has not been returned to the manufacturer for evaluation.

• Brand Name: BARD POWERMIDLINE CATHETER 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: maddy vincent ; 605 north 5600 west; salt lake city 84116 ; 8015950700
• MDR Report Key: 18909619
• MDR Text Key: 337761147
• Report Number: 3006260740-2024-01120
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K153393
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Pharmacist
• Type of Report: Initial
• Report Date: 02/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: N/A
• Device Catalogue Number: P6154208
• Device Lot Number: REGZ0066
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/22/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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