BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CLEANOP KIT

    MDR report key: 6414638 · Received March 17, 2017

    Report

    Report Number
    3011699859-2017-00001
    Event Type
    Injury
    Date Received
    March 17, 2017
    Date of Event
    February 14, 2017
    Report Date
    February 15, 2017
    Manufacturer
    MICROTEK MEDICAL, INC.
    Product Code
    KME
    PMA / PMN Number
    EXEMPT
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NM, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED FOR THIS LOT OF PRODUCT CHSMF-02D LOT J17024. PER THE BOM THE LOT OF BSTF USED WAS 161017Z. NO INCOMING INSPECTION REPORT IS AVAILABLE FOR AFFECTED PART # BSTF LOT # 161017Z DUE TO THE SKIP LOT PROCESS. HOWEVER, RAW MATERIAL INSPECTION REPORT OF THE LOT INSPECTED BEFORE (161007Z) AND THE LOT INSPECTED AFTER (161105Z) THE AFFECTED LOT, WERE REVIEWED. NO BROKEN OR DAMAGED STRAPS OR RINGS (BUCKLES) WERE REPORTED IN ANY OF THE TWO RAW MATERIAL INSPECTION REPORTS. SAMPLES OF AFFECTED BSTF LOT # 161017Z WERE SENT TO RD&E FOR FURTHER INVESTIGATION. THE DEFECTIVE PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE NON-CONFORMITY COULD NOT BE VERIFIED AND THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED FOR THIS LOT OF PRODUCT CHSMF-02D LOT J17024. PER THE BOM THE LOT OF BSTF USED WAS 161017Z. NO INCOMING INSPECTION REPORT IS AVAILABLE FOR AFFECTED PART # BSTF LOT # 161017Z DUE TO THE SKIP LOT PROCESS. HOWEVER, RAW MATERIAL INSPECTION REPORT OF THE LOT INSPECTED BEFORE (161007Z) AND THE LOT INSPECTED AFTER (161105Z) THE AFFECTED LOT, WERE REVIEWED. NO BROKEN OR DAMAGED STRAPS OR RINGS (BUCKLES) WERE REPORTED IN ANY OF THE TWO RAW MATERIAL INSPECTION REPORTS. SAMPLES OF AFFECTED BSTF LOT # 161017Z WERE SENT TO RD&E FOR FURTHER INVESTIGATION. THE DEFECTIVE PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE NON-CONFORMITY COULD NOT BE VERIFIED AND THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED.

    Additional Manufacturer Narrative · 1

    THE DHR WAS REVIEWED FOR THIS LOT OF PRODUCT CHSMF-02D LOT J17024. PER THE BOM THE LOT OF BSTF USED WAS 161017Z. NO INCOMING INSPECTION REPORT IS AVAILABLE FOR AFFECTED PART # BSTF LOT # 161017Z DUE TO THE SKIP LOT PROCESS. HOWEVER, RAW MATERIAL INSPECTION REPORT OF THE LOT INSPECTED BEFORE (161007Z) AND THE LOT INSPECTED AFTER (161105Z) THE AFFECTED LOT, WERE REVIEWED. NO BROKEN OR DAMAGED STRAPS OR RINGS (BUCKLES) WERE REPORTED IN ANY OF THE TWO RAW MATERIAL INSPECTION REPORTS. SAMPLES OF AFFECTED BSTF LOT # 161017Z WERE SENT TO RD&E FOR FURTHER INVESTIGATION. THE DEFECTIVE PRODUCT WAS NOT RETURNED FOR EVALUATION; THEREFORE, THE NON-CONFORMITY COULD NOT BE VERIFIED AND THE ROOT CAUSE FOR THE EVENT HAS NOT BEEN DETERMINED. FOLLOW UP 2: DHR REVIEW: THE SUPPLIER HAS REVIEWED PRODUCTION RECORDS ASSOCIATED WITH THIS LOT AND NO ISSUES WERE FOUND. PERSONNEL REVIEW: THE STRAP BUCKLE IS MANUALLY SEWN INTO THE STRAP BY THE SUPPLIER. PROCESS REVIEW: THE BUCKLES ARE INJECTION MOLDED. THE SUPPLIER HAS CHECKED RECORDS AND FOUND THIS PROCESS WAS PERFORMED TO SPECIFICATION.   MATERIAL REVIEW: THE MATERIAL FOR THE BSTF STRAP IS POLYPROPYLENE. THE SUPPLIER HAS CHECKED RECORDS AND FOUND THIS MATERIAL WAS INDEED USED FOR THE BUCKLES WITHIN THE LOT REPORTED.   WE DID NOT SECURE ANY PHYSICAL RETURNS FROM THE CUSTOMER. HOWEVER, WE DID RECEIVE A PHOTO OF A UNIT WITH BROKEN STRAP AND HAVE BEEN ABLE TO DUPLICATE THE SAME BREAKING AREA IN OUR TESTING. THIS IS THE FIRST INCIDENCE OF STRAP-BUCKLE BREAKING IN THE PAST 4 YEARS. IN THAT TIME MILLIONS OF STRAPS HAVE BEEN BUILT AND SOLD WITHOUT ISSUE, AT A RATE OF APPROXIMATELY 1 MILLION USED PER YEAR. THIS STRAP IS USED IN DIFFERING WAYS DEPENDING ON THE SITUATION. IN THIS CASE WE WERE ABLE TO GET INFORMATION FROM THE CUSTOMER ON THE SPECIFICS OF THE PATIENT/POSITION AND HOW THE STRAP WAS USED, AND DID NOT SEE ANY OBVIOUS EVIDENCE OF MISUSE. HOWEVER, WE COULD NOT BE CERTAIN OF WHAT EXACTLY HAPPENED WITH THE STRAP THAT BROKE, AS THE SAMPLE WAS NOT SENT BACK TO US. BASED ON THE DHR RECORDS SHOWING IN-TOLERANCE, COMBINED WITH THE FACT THIS IS A SINGLE OCCURRENCE, WE DO NOT HAVE ANY EVIDENCE THAT OUR SUPPLIER HAS DONE ANYTHING WRONG. FOR THIS REASON, WE CANNOT ISSUE A COMPLAINT TO OUR SUPPLIER (JUSTIFICATION). UNFORTUNATELY, THE INFORMATION WE HAVE CANNOT POINT TO A DEFINITIVE CONCLUSION AND WE HAVE TO CALL THE INVESTIGATION INCONCLUSIVE.  DESPITE OUR CONCLUSION, WE ARE CONCERNED ABOUT RECEIVING EVEN 1 OF THESE COMPLAINTS AND DO WANT TO TAKE EFFORTS TO ENSURE THE EVENT WILL NOT REOCCUR. AS A RESULT, WE HAVE DECIDED TO CHANGE THE MATERIAL OF THE BUCKLE. IT IS CURRENTLY POLYPROPYLENE AND WE ARE CHANGING IT TO POLYETHYLENE. WE HAVE PERFORMED STRENGTH TESTING AND FOUND THAT BUCKLES MADE OUT OF POLYETHYLENE ARE SIGNIFICANTLY STRONGER THAN THE CURRENT MATERIAL, POLYPROPYLENE. WE EXPECT THAT THE MATERIAL CHANGE WILL IMPROVE THE STRENGTH OF THE BUCKLE TO SO THAT THIS EVENT WILL NOT REOCCUR.

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED STATED THAT THE PATIENT WAS PLACED FLAT ON THE TABLE IN THE SUPINE POSITION WITH A TEN DEGREE ANGLE TO THE LEFT. THE STRAPS WERE PLACED AROUND THE PATIENTS LEGS AND WHEN THE STRAPS BROKE AND THE PATIENT FELL FROM THE TABLE, 3 STAFF MEMBERS PULLED MUSCLES IN THEIR BACKS. A MEDWATCH FORM WAS LATER RECEIVED WITH THE FOLLOWING INFORMATION: "PATIENT WAS UNDERGOING A LAPAROSCOPIC APPENDECTOMY. HE WAS POSITIONED IN TRENDELENBURG WITH A 45 DEGREE TILT TO THE LEFT SIDE. A STRAP WAS PLACED AROUND HIS THIGHS FOR POSITIONING. DURING THE PROCEDURE, THE PLASTIC LOOP ON THE STRAP BROKE AND THE PATIENT SLID TOWARD THE FLOOR. HE WAS CAUGHT AND EASED DOWN BY THE SURGEON AND TECHS WHO WERE ON THE LEFT SIDE OF THE BED. AT THE TIME THE STRAP BROKE THE PATIENT HAD THREE TROCARS INSERTED IN HIS ABDOMEN AS WELL AS AN ENDOTRACHEAL TUBE THAT WAS DISLODGED. HIS HEAD DID NOT HIT THE FLOOR BUT DID HIT THE IV POLE STAND BEHIND THE TABLE. HE WAS LIFTED BACK ONTO THE TABLE, THE TROCARS WERE REMOVED, HE WAS RE-PREPPED AND DRAPED AND TROCARS INSERTED INTO THE ORIGINAL TRACTS. THERE WAS NO DAME NOTED UPON DIRECT VISUALIZATION. HE WAS RE-INTUBATED EASILY WITHOUT EVIDENCE OF TRAUMA. HE SUSTAINED A SMALL HEMATOMA ON HIS LEFT FOREHEAD THAT DISAPPEARED WITHIN 2-3 DAYS. X-RAYS DEMONSTRATED NO INJURIES. HE REMAINED HOSPITALIZED FOR 8 DAYS OF IV ANTIBIOTICS DUE TO A DIAGNOSIS OF PERITONITIS PRIOR TO SURGERY."

    Description of Event or Problem · 1

    THE PATIENT WAS PLACED FLAT ON THE TABLE IN THE SUPINE POSITION WITH A TEN DEGREE ANGLE TO THE LEFT. THE STRAPS WERE PLACED AROUND THE PATIENTS LEGS AND WHEN THE STRAPS BROKE AND THE PATIENT FELL FROM THE TABLE, 3 STAFF MEMBERS PULLED MUSCLES IN THEIR BACKS.

    Description of Event or Problem · 1

    INITIAL INFORMATION RECEIVED STATED THAT THE PATIENT WAS PLACED FLAT ON THE TABLE IN THE SUPINE POSITION WITH A TEN DEGREE ANGLE TO THE LEFT. THE STRAPS WERE PLACED AROUND THE PATIENTS LEGS AND WHEN THE STRAPS BROKE AND THE PATIENT FELL FROM THE TABLE, 3 STAFF MEMBERS PULLED MUSCLES IN THEIR BACKS. A MEDWATCH FORM WAS RECEIVED ON (B)(6) 2017 WITH THE FOLLOWING INFORMATION: "PATIENT WAS UNDERGOING A LAPAROSCOPIC APPENDECTOMY. HE WAS POSITIONED IN TRNDELENBURG WITH A 45 DEGREE TILT TO THE LEFT SIDE. A STRAP WAS PLACED AROUND HIS THIGHS FOR POSITIONING. DURING THE POCEDURE, THE PLASTIC LOOP ON THE STRAP BROKE AND THE PATIENT SLID TOWARD THE FLOOR. HE WAS CAUGHT AND EASED DOWN BY THE SURGEON AND TECHS WHO WERE ON THE LEFT SIDE OF THE BED. AT THE TIME THE STRAP BROKE THE PATIENT HAD THREE TROCARS INSERTED IN HIS ABDOMEN AS WELL AS AN ENDOTRACHAEL TUBE THAT WAS DISLODGED. HIS HEAD DID NOT HIT THE FLOOR BUT DID HIT THE IV POLE STAND BEHIND THE TABLE. HE WAS LIFTED BACK ONTO THE TABLE, THE TROCARS WERE REMOVED, HE WAS RE-PREPPED AND DRAPED AND TORCARS INSERTED INTO THE ORIGINAL TRACTS. THERE WAS NO DAME NOTED UPON DIRECT VISUALIZATION. HE WAS RE-INTUBATED EASILY WITHOUT EVIDENCE OF TRAUMA. HE SUSTAINED A SMALL HEMATOMA ON HIS LEFT FOREHEAD THAT DISAPPEARED WITHIN 2-3 DAYS. X-RAYS DEMONSTRATED NO INJURIES. HE REMAINED HOSPITALIZED FOR 8 DAYS OF IV ANTIBIOTICS DUE TO A DIAGNOSIS OF PERITONITIS PRIOR TO SURGERY."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    195929 CLEANOP KIT DISPOSABLE MEDICAL BEDDING KME MICROTEK MEDICAL, INC. CHSMF-02D LOT J17024

    Patients

    Seq Age Sex Outcome Treatment
    1 Other