HALYARD VIDEO DRAPE 5IN - 96IN
Report
- Report Number
- 3014421917-2024-00004
- Event Type
- Injury
- Date Received
- June 18, 2024
- Date of Event
- March 27, 2024
- Report Date
- August 14, 2024
- Manufacturer
- O&M HALYARD, INC.
- Product Code
- KKX
- UDI-DI
- 10680651517392
- PMA / PMN Number
- K101689
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
A SAMPLE WAS NOT AVAILABLE FOR EVALUATION. O&M HALYARD, INC. IS THE INITIAL IMPORTER AND REPACKAGER/RELABELLER ESTABLISHMENT OF THE HALYARD VIDEO DRAPE 5IN - 96IN. THE COMPLAINT PRODUCT IS MANUFACTURED BY EXACT MEDICAL MANUFACTURING, INC (FDA REGISTRATION NUMBER (B)(4). A SUPPLIER CORRECTIVE ACTION (SCAR) WAS SUBMITTED TO THE MANUFACTURER ON MAY 24,2024. A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE MANUFACTURER. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP(B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT A O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY. H3 OTHER TEXT : DEVICE NOT RETURNED.
* CORRECTION REPORT: ADDED RELATED REPORT NUMBER (B)(4) IN H10 FOR MEDWATCH RECEIVED, THIS WAS OMITTED IN ERROR ON INITIAL REPORT SUBMISSION.* A FOLLOW-UP REPORT WILL BE PROVIDED UPON CONCLUSION OF INVESTIGATION AND RESPONSE BY THE MANUFACTURER. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP-GHC-24-00315. THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
AN ACTUAL SAMPLE OR DEFECT PHOTO WAS NOT AVAILABLE. THE DEVICE HISTORY RECORD WAS REVIEWED AND CONFIRMED PRODUCT WAS MANUFACTURED ACCORDING TO APPROVED SPECIFICATIONS. INVESTIGATION OF INCIDENT FOUND END-USER WAS NOT UTILIZING THIS DRAPE CORRECTLY. THE PERFORATED TIP IS MEANT TO BE REMOVED AND IS NOT INTENDED TO SERVE AS A STERILE BARRIER. AN O&M SALES TEAMMATE IS WORKING WITH THE CUSTOMER TO PROVIDE THEM FURTHER EDUCATION ON THE CORRECT DRAPE FOR THE INTENDED USE THEY ARE SEEKING. THIS IS THE FIRST AND ONLY PRODUCT COMPLAINT ON THIS PRODUCT SINCE SALES INITIATED IN 2022. THERE IS NO TREND FOR THIS ISSUE. COMPLAINTS ARE MONITORED ON A MONTHLY BASIS TO IDENTIFY ANY COMPLAINT TRENDS WHICH REQUIRE CORRECTIVE ACTION, AT THIS TIME THIS INCIDENT APPEARS ISOLATED. THIS PRODUCT INCIDENT IS DOCUMENTED IN THE O&M HALYARD, INC. COMPLAINT DATABASE AND IDENTIFIED AS COMPLAINT COMP (B)(4). THIS INFORMATION IS SUBMITTED PURSUANT TO 21CFR803, IN COMPLIANCE WITH THE MEDICAL DEVICE REPORTING REQUIREMENT AND SHOULD NOT BE CONSIDERED TO BE AN ADMISSION THAT AN O&M HALYARD, INC. PRODUCT IS DEFECTIVE OR HAS CAUSED SERIOUS INJURY.
CUSTOMER REPORTED THAT THE NODE NAVIGATOR WAS PROPERLY DRAPED AND SECURED WITH VIDEO DRAPE. DURING RIGHT SEED LOCALIZED PARTIAL MASTECTOMY PROCEDURE, IT WAS NOTED BY THE SURGEON THAT THE PERFORATED END OF THE VIDEO DRAPE WAS SEPARATED. THIS CAUSED THE PROBE TO BE EXPOSED. THE PROCEDURE WAS EXTENDED DUE TO HAVING TO REESTABLISH STERILE FIELD AND RE-WRAP THE PROBE WITH DRAPE. STAFF HAVE STARTED RELOCATING THE PROBE END TO ANOTHER LOCATION AND SECURING WITH THE STERILE TAPE PROVIDED IN THE DRAPE KIT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2316691 | HALYARD VIDEO DRAPE 5IN - 96IN | SURGICAL DRAPES AND PACKS | KKX | O&M HALYARD, INC. | 51739 | 2202E197 | 10680651517392 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |