MAUDE Adverse Event Report: MEDLINE INDUSTRIES, LP - NORTHFIELD MEDLINE PENROSE DRAIN; SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE

Model Number DYND50428

Device Problems Break (1069); Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 08/08/2022

Event Type  malfunction  

Event Description

Drain cut to 16 cm for use as retractor for hiatal hernia repair.Drain torn and 2cm piece broke away.Discovered during surgery and removed.Drain pieces all placed together and full drain accounted for.Management notified.Defective product form complete.Drain placed in biohazard bag for further examination and given to management.Fda safety report id# (b)(4).

• Brand Name: MEDLINE PENROSE DRAIN
• Type of Device: SYSTEM, URINE DRAINAGE, CLOSED, FOR NONINDWELLING CATHETER, STERILE
• Manufacturer (Section D): MEDLINE INDUSTRIES, LP - NORTHFIELD
• MDR Report Key: 15250417
• MDR Text Key: 298400675
• Report Number: MW5111567
• Device Sequence Number: 1
• Product Code: NNZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 08/16/2022

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 Model Number: DYND50428
• Device Lot Number: 59221122514
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/17/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 40 YR
• Patient Sex: Female
• Patient Weight: 93 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White