MAUDE Adverse Event Report: CAREFUSION 2200, INC. V. MUELLER NEUROLOGICAL/SPINE STERILE PATTIES; NEUROSURGICAL PADDIE

Model Number NL9051

Device Problems Peeled/Delaminated (1454); Material Split, Cut or Torn (4008)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/29/2018

Event Type  malfunction  

Event Description

The patties have strings which are easy to come off and the patties shred against the tissue and the bones.

• Brand Name: V. MUELLER NEUROLOGICAL/SPINE STERILE PATTIES
• Type of Device: NEUROSURGICAL PADDIE
• Manufacturer (Section D): CAREFUSION 2200, INC.; 75 north fairway drive; vernon hills IL 60061
• MDR Report Key: 7859388
• MDR Text Key: 119647868
• Report Number: 7859388
• Device Sequence Number: 1
• Product Code: HBA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 08/30/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Model Number: NL9051
• Device Catalogue Number: NL9051
• Device Lot Number: L0408
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/30/2018
• Event Location: Hospital
• Date Report to Manufacturer: 09/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1