PENDINGRecalls & reported problems across all models

We found 5 models of PENDING by Medline Industries, Inc. in the FDA's device registry (GUDID). Together they are named in 6 adverse event reports in the FDA's MAUDE database, received between Aug 21, 2019 and Jun 27, 2023 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Break” (3 reports).

1 FDA recall record name at least one of these models by its device identifier, 1 still open.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

PENDING recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. May 25, 2022Class IIOpen, Classified

   Facility Temperature excursions (from June 2021-August 2021) prior to delivery; exposure to higher temperatures may have impacted product effectiveness. All lots received between 06/01/21-9/30/21.

   Z-1596-2022 · Root cause: Environmental control · Recall details · FDA record ↗

Most reported PENDING problems

PENDING models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• PENDING EMZH60051

  Heparin, vascular access flush
  1 recall0 reports
• PENDING MMPF1110T

  Trousers, anti-shock
  2 reports
• PENDING HCSU4514

  CANNULA, NASAL, OXYGEN
  2 reports
• PENDING MSG09150

  SCREWDRIVER
  1 report
• PENDING MMPF1110

  BENDER
  1 report

Recent PENDING adverse event reports

The 6 most recent reports across all models, in the reporter's own words as published by the FDA.

• MalfunctionJun 27, 2023Material Integrity Problem; Material Integrity Problem

  GUIDEWIRE BROKE IN TWO PIECES DURING PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17210284 ↗
• InjuryNov 2, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACCORDING TO THE CUSTOMER, THE PATIENT HAD BEEN WEARING THE NASAL CANNULA FOR 5 DAYS WHEN A 'RIGHT EAR STAGE 3 PRESSURE INJURY AND LEFT EAR STAGE 2 PRESSURE INJURY' WAS IDENTIFIED 'WHERE THE NASAL CANNULA RESTS AGAINST THE SKIN'.

  Patient problems: Tissue Breakdown

  MAUDE report 15718066 ↗
• InjuryMay 26, 2022Break

  ACCORDING TO THE FACILITY DURING A PROCEDURE THE 'BB TAKS BROKE INSIDE THE PATIENT AND HAD TO REMOVED'.

  Patient problems: Foreign Body In Patient

  MAUDE report 14516214 ↗
• InjuryApr 20, 2022Break

  ACCORDING TO THE FACILITY DURING A PROCEDURE THE 'BB TAKS BROKE INSIDE THE PATIENT AND THE DOCTOR HAD TO REMOVE THEM'.

  Patient problems: Foreign Body In Patient

  MAUDE report 14160651 ↗
• MalfunctionSep 22, 2020Break; Break

  IT WAS REPORTED THAT THE WIRES BROKE WHILE BEING SECURED. THE ENDS OF THE BROKEN WIRES REMAIN IN THE PATIENT'S FOOT DUE TO THE BENEFIT OUTWEIGHING THE RISK OF REMOVAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10568003 ↗
• InjuryAug 21, 2019Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT TANGLED UP IN THE 25 FEET OXYGEN TUBING CONNECTOR AND 7 FEET NASAL CANNULA. PATIENT SUSTAINED RIGHT PATELLAR FRACTURE.

  Patient problems: Bone Fracture(s)

  MAUDE report 8915387 ↗

Other Medline Industries, Inc. products

• Centurion Medical Products Corp52 models · 10 reports · 32 recalls
• NAMIC667 models · 229 reports · 22 recalls
• CURAD85 models · 295 reports · 4 recalls
• HUDSON RCI30 models · 190 reports · 2 recalls
• Excelsior8 models · 47 reports · 3 recalls
• BAUSCH and LOMB6 models · 1 reports · 2 recalls
• Medline ReNewal18 models · 34 reports · 1 recall
• Guardian15 models · 77 reports