MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC. MEDLINE INDUSTRIES, INC.; PLASTIC SURGERY AND ACCESSORIES KIT

Model Number DYNJ82495A

Device Problems Product Quality Problem (1506); Therapeutic or Diagnostic Output Failure (3023)

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

Event Date 03/21/2023

Event Type  malfunction  

Event Description

Three skin staplers not working properly during this case.One skin stapler was inside the medline plastic pack, code: do, lot# 22lbj497, re-order#: dynj82495a, expiration date: [redacted date], gtin: (01)10195327308964.The other two skin staplers were individually wrapped.First: covidien appose ulc auto suture slim body skin stapler 35w, ref# 8886803712, lot# j2m1452ly, exp: [redacted date].Second individually wrapped skin stapler: covidien appose ulc auto suture slim body skin stapler 35w, ref# 8886803712, lot# j2j0414ly, exp: [redacted date].Skin staplers malfunctioning reported to md, pod leader, team aware.Three malfunctioning skin staplers collected and given to pod leader.New skin staplers used, no harm to the patient.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Type of Device: PLASTIC SURGERY AND ACCESSORIES KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; one medline pl.; mundelein IL 60060
• MDR Report Key: 16681471
• MDR Text Key: 312687653
• Report Number: 16681471
• Device Sequence Number: 1
• Product Code: FTN
• 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: 03/24/2023

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: Other
• Device Model Number: DYNJ82495A
• Device Catalogue Number: DYNJ82495A
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 03/24/2023
• Event Location: Hospital
• Date Report to Manufacturer: 04/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/05/2023
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 16060 DA
• Patient Sex: Female