MEDLINE-MICROTEK
Received Jun 23, 2026 · Event occurred May 5, 2026
Report 3012811961-2026-00012 · MDR key 25602397
Device
Generic name
Warmer Drape, For Use With Ors-2000 Series Fluid Warming System, 112 Cm X 112 Cm
Manufacturer
Microtek Medical LlcModel number
ORS-100Product problems
- Material Puncture/Hole
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE MANUFACTURER RECEIVED A COMPLAINT INDICATING THAT A STERILE WARMING DRAPE (ORS-100) EXHIBITED TINY PIN-SIZE HOLES DURING USE. ONE UNIT WAS AFFECTED; HOWEVER, THE LOT NUMBER COULD NOT BE CONFIRMED. NO PHYSICAL SAMPLE WAS RETURNED FOR EVALUATION; THEREFORE, THE INVESTIGATION WAS BASED ON AN IMAGE PROVIDED BY THE CUSTOMER. THE REPORTED DEFECT WAS CONFIRMED BASED ON THE AVAILABLE EVIDENCE, BUT THE CONDITION COULD NOT BE REPLICATED. A REVIEW OF MANUFACTURING, MATERIAL, PROCESS, EQUIPMENT, ENVIRONMENTAL, AND PERSONNEL FACTORS DID NOT IDENTIFY ANY CONTRIBUTING CAUSE. DEVICE TRACEABILITY COULD NOT BE ESTABLISHED DUE TO THE ABSENCE OF A VALID LOT NUMBER. BASED ON THE AVAILABLE INFORMATION, THE INVESTIGATION WAS DETERMINED TO BE INCONCLUSIVE. THE COMPLAINT WILL CONTINUE TO BE MONITORED FOR POTENTIAL TREND.
Description of Event or Problem
IT WAS REPORTED THAT THE CUSTOMER OBSERVED TINY PIN-SIZE HOLES IN A STERILE WARMING DRAPE (ORS-100) DURING USE. ONE UNIT WAS AFFECTED. THE LOT NUMBER COULD NOT BE CONFIRMED. NO PATIENT INJURIES, INFECTIONS, OR COMPLICATIONS WERE REPORTED.