MAUDE Adverse Event Report: BARD BARD; MIDLINE CATHETER

Lot Number REFV3375

Device Problems Break (1069); Positioning Failure (1158); Entrapment of Device (1212); Difficult to Remove (1528); Unraveled Material (1664); Physical Resistance/Sticking (4012)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 12/03/2021

Event Type  malfunction  

Event Description

Adult male with history of chronic kidney disease stage iii, chronic pain, covid-19 pneumonia admitted during fall 2021 with acute hypoxic respiratory failure due to covid pneumonia.Vascular access rn was placing a midline catheter on pt in right upper extremity (rue) cephalic vein.Access to vein obtained and wire threaded into needle.Upon threading wire, resistance was noted so wire was pulled out.Wire was reinserted without resistance for approximately 8cm and then resistance was met again.Wire pulled back a second time, but rn met resistance when pulling back.Needle removed and the rest of the wire came with it but was unraveled.Manager and md notified, x-ray obtained of the arm, and it was identified that a 2-inch piece was in the superficial tissue of the arm.The decision made to not retrieve the retained portion due to the status of this patient.Peripheral iv placed.No device nor packaging retained.

• Brand Name: BARD
• Type of Device: MIDLINE CATHETER
• Manufacturer (Section D): BARD; 605 north 5600 west; salt lake city UT 84116
• MDR Report Key: 13415487
• MDR Text Key: 284813570
• Report Number: 13415487
• Device Sequence Number: 1
• Product Code: PND
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 12/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Lot Number: REFV3375
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 12/08/2021
• Event Location: Hospital
• Date Report to Manufacturer: 02/01/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 22630 DA
• Patient Sex: Male
• Patient Weight: 118 KG
• Patient Race: White