MAUDE Adverse Event Report: C. R. BARD, INC. MIDLINE CATHETER

Model Number REFW2387

Device Problem Material Frayed (1262)

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

Event Date 01/17/2022

Event Type  Injury  

Event Description

Picc line trained staff attempting to insert midline; attempted six (6) times to insert midline; prior five (5) midlines were noted with flared ends, preventing the insertion of the midline cath.This is effecting the following lot numbers: 4292, 1083, 0285, 4426; model numbers: reez1083 / reey0285 / reft4292 / redu4426 / refw2387.Fda safety report id# (b)(4).

• Brand Name: MIDLINE CATHETER
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): C. R. BARD, INC.
• MDR Report Key: 13315387
• MDR Text Key: 284325391
• Report Number: MW5106870
• Device Sequence Number: 5
• Product Code: PND
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 01/18/2022
• 5 Devices were Involved in the Event: 1 2 3 4 5

1 Patient was Involved in the Event

• Date FDA Received: 01/20/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: REFW2387
• Is the Reporter a Health Professional?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White