CHLORAPREP ONE STEP
Report
- Report Number
- 3004932373-2021-00535
- Event Type
- Malfunction
- Date Received
- December 13, 2021
- Date of Event
- November 16, 2021
- Report Date
- January 6, 2022
- Manufacturer
- CAREFUSION 213, LLC 0113
- Product Code
- KXG
- PMA / PMN Number
- EXEMPT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
(B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
A PHOTO HAS BEEN PROVIDED FOR EVALUATION. VISUAL EXAMINATION OF THE PHOTO SHOWS A HAIR WITHIN THE PACKAGING OF THE APPLICATOR WHICH VERIFIES THE REPORTED ISSUE. THE HAIR ORIGINATES FROM AN OPERATOR. THE PROCESS HAS CERTAIN MANUAL PROCESSES THAT MAY RESULT IN HAIR ON THE PRODUCT. THE MOST PROBABLE ROOT CAUSE IS INADEQUATE GOWNING BY ASSOCIATE(S) AND/OR PREVENTIVE MEASURES DURING THE MANUFACTURING OF THE PRODUCT. A PRODUCTION RECORD REVIEW WAS COMPLETED FOR BATCH/LOT 1214269 AND NO NON-CONFORMANCE WAS NOTED DURING THE MANUFACTURING OF THIS LOT. CORRECTIVE ACTIONS INCLUDE THE MODIFICATION AND UTILIZATION OF ANTI-ELECTROSTATIC LAB COATS TO DECREASE THE POSSIBILITY TO ANY FOREIGN MATTER GOING FORWARD DURING MANUFACTURING. NO FURTHER ACTION IS REQUIRED. THIS FAILURE WILL CONTINUE TO BE TRACKED AND TRENDED.
(B)(6) INITIAL EMDR SUBMISSION. A FOLLOW UP EMDR WILL BE SUBMITTED IF ADDITIONAL INFORMATION BECOMES AVAILABLE. (B)(4).
IT WAS REPORTED THAT THERE WAS A HAIR IN THE PACKAGE. VERBATIM: WHEN THIS PACK OF 930700 WAS OPENED, THERE WAS A HAIR IN THE PACKAGE. DO WE NEED TO PICK UP THE ITEM FROM THEM? (TO RETURN TO VENDOR). I AM GOING TO RE-SHIP THE ITEM BUT JUST WANTED TO KNOW IF WE NEED TO GET THE PRODUCT BACK THAT¿S DAMAGED? (WITH HAIR). PLEASE SEE PICTURE BELOW OF ITEM #930700 THAT HAD A HAIR INSIDE THE PACKAGING. PLEASE LET ME KNOW IF YOU WOULD LIKE THIS BACK FOR QA OR NOT. PLEASE SEE THE BELOW REPORT OF MATERIAL 930700 HAVING A HAIR INSIDE OF THE PACKAGING. THE CUSTOMER DID DISCARD THE PRODUCT, BUT DOES HAVE A PHOTO OF THE INCIDENT. THE CONTACT INFORMATION IS BELOW.
IT WAS REPORTED THAT THERE WAS A HAIR IN THE PACKAGE. VERBATIM: WHEN THIS PACK OF 930700 WAS OPENED, THERE WAS A HAIR IN THE PACKAGE. SEE BELOW. DO WE NEED TO PICK UP THE ITEM FROM THEM? (TO RETURN TO VENDOR). I AM GOING TO RE-SHIP THE ITEM BUT JUST WANTED TO KNOW IF WE NEED TO GET THE PRODUCT BACK THAT¿S DAMAGED? (WITH HAIR). PLEASE SEE PICTURE BELOW OF ITEM #930700 THAT HAD A HAIR INSIDE THE PACKAGING. PLEASE LET ME KNOW IF YOU WOULD LIKE THIS BACK FOR QA OR NOT. PLEASE SEE THE BELOW REPORT OF MATERIAL 930700 HAVING A HAIR INSIDE OF THE PACKAGING. THE CUSTOMER DID DISCARD THE PRODUCT, BUT DOES HAVE A PHOTO OF THE INCIDENT.
IT WAS REPORTED THAT THERE WAS A HAIR IN THE PACKAGE. VERBATIM: WHEN THIS PACK OF 930700 WAS OPENED, THERE WAS A HAIR IN THE PACKAGE. SEE BELOW. DO WE NEED TO PICK UP THE ITEM FROM THEM? (TO RETURN TO VENDOR). I AM GOING TO RE-SHIP THE ITEM BUT JUST WANTED TO KNOW IF WE NEED TO GET THE PRODUCT BACK THAT¿S DAMAGED? (WITH HAIR). PLEASE SEE PICTURE BELOW OF ITEM #930700 THAT HAD A HAIR INSIDE THE PACKAGING. PLEASE LET ME KNOW IF YOU WOULD LIKE THIS BACK FOR QA OR NOT. PLEASE SEE THE BELOW REPORT OF MATERIAL 930700 HAVING A HAIR INSIDE OF THE PACKAGING. THE CUSTOMER DID DISCARD THE PRODUCT, BUT DOES HAVE A PHOTO OF THE INCIDENT. THE CONTACT INFORMATION IS BELOW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1889033 | CHLORAPREP ONE STEP | 2% W/V CHLORHEXIDINE GLUCONATE/70% V/V ISOPROPYL ALCOHOL | KXG | CAREFUSION 213, LLC 0113 | 1214269 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Other |