PROLENE BLUE 1.0M 90CM W/NDL
Report
- Report Number
- 2210968-2021-00025
- Event Type
- Malfunction
- Date Received
- January 4, 2021
- Date of Event
- December 11, 2020
- Report Date
- December 11, 2020
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- K133356
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- RS
- Reporter Occupation
- OTHER
Narratives
DATE SENT TO THE FDA: 04/21/2021. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: 1. DID THE PATIENT STILL DEVELOPED NAUSEA, VOMITING AND HEADACHE AFTER SURGERY EVEN AFTER PREVENTATIVE LATRAN MEDICATION WAS GIVEN? IF YES, HOW WAS THE NAUSEA, VOMITING AND HEADACHE TREATED? PLEASE SPECIFY. - DUE TO THE INCREASE OF THE OPERATION TIME BY 15-20 MINUTES, THE PATIENT WAS PRESCRIBED LATRAN TO PREVENT VOMITING AND NAUSEA. AFTER TAKING THE LATRAN, THE PATIENT DID NOT EXPERIENCE ANY NEGATIVE PHENOMENA. 2. PLEASE CONFIRM IF TOTAL QUANTITY OF 3 INVOLVED IN THE EVENT AS RESPONSE #1 HAS TWO DIFFERENT STATEMENTS. - DURING THE APPLICATION OF THE VASCULAR ANASTOMOSIS, ONLY 3 THREADS WERE TORN. THE FOURTH THREAD WAS ABLE TO SEW UP WITHOUT NEGATIVE CONSEQUENCES. 3. WHEN DID ALL PULL OFFS/DETACHMENTS HAPPEN: DURING USE/SUTURING ON THE PATIENT OR DURING PACKAGE OPENING OR DISPENSING? PLEASE SPECIFY FOR EACH PULL OFF/DETACHMENT. - ALL THREE THREADS WERE SEPARATED FROM THE NEEDLE SEQUENTIALLY WHEN A VASCULAR ANASTOMOSIS WAS APPLIED. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
DATE SENT TO THE FDA: 04/07/2021 ADDITIONAL 6. HEALTH EFFECT - IMPACT CODE: F1908 ATTEMPTS ARE BEING MADE TO CLARIFY THE FOLLOWING INFORMATION. TO DATE NO RESPONSE HAS BEEN PROVIDED. IF FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. UPON FURTHER REVIEW OF ADDITIONAL INFORMATION AND COMPARING WITH PREVIOUS INFORMATION REPORTED, CLARIFICATION NEEDED FOR THE FOLLOWING: 1. WHEN WERE ALL PULL OFFS/DETACHMENTS HAPPENED: DURING USE/SUTURING ON THE PATIENT OR DURING PACKAGE OPENING OR DISPENSING? PLEASE SPECIFY FOR EACH PULL OFF/DETACHMENT. 2. PLEASE CONFIRM IF TOTAL QUANTITY OF 3 SUTURES INVOLVED IN THE EVENT. 3. DID THE PATIENT STILL DEVELOP NAUSEA, VOMITING AND HEADACHE AFTER SURGERY EVEN AFTER THE PREVENTATIVE LATRAN MEDICATION WAS GIVEN? IF YES, HOW WAS THE NAUSEA, VOMITING AND HEADACHE TREATED? PLEASE SPECIFY. ADDITIONAL INFORMATION WAS REQUESTED, AND THE FOLLOWING WAS OBTAINED: WHETHER THERE WERE ANY ADVERSE CONSEQUENCES FOR THE PATIENT. - THERE WERE NO ADVERSE CONSEQUENCES FOR THE PATIENT, THE ONLY THING WAS THAT THE OPERATION TIME (HEART TRANSPLANTATION) INCREASED, WHICH AFFECTED THE TIME THE PATIENT SPENT UNDER ANESTHESIA. HAS THE PATIENT'S TREATMENT OR POSTOPERATIVE CARE CHANGED DUE TO THE INCREASED TIME OF SURGERY? - POSTOPERATIVE PATIENT CARE HAS CHANGED. SHE DEVELOPED NAUSEA, VOMITING, HEADACHE DUE TO PROLONGED STAY UNDER ANESTHESIA. IF YES, PLEASE EXPLAIN. --- 1. WAS THERE THE DETACHMENT/PULL OFF AND AT THE SAME TIME FRAYING OCCURRED WITH ALL THREE SUTURES? ¿ THE SEPARATION OF THE NEEDLE FROM THE THREAD OCCURRED DURING THE APPLICATION OF THE VASCULAR SUTURE THREE TIMES. THE FIRST TIME THE SUTURE DETACHED FROM THE NEEDLE OCCURRED WHEN THE SURGEON APPLIED A SUTURE TO THE VASCULAR ANASTOMOSIS, THEN 3 MORE SUTURE ATTEMPTS WERE MADE, WITH THE SAME EFFECT OF DETACHING THE SUTURE FROM THE NEEDLE. 2. WHEN DID IT HAPPEN: DURING USE / SUTURING ON THE PATIENT OR DURING OPENING OR DISPENSING? ¿ SUTURE DETACHMENT FROM THE NEEDLE OCCURRED DURING SUTURE PLACEMENT ON THE ANASTOMOSIS. 3. WAS THE OPERATION TIME OF 15-20 MINUTES INCREASED DUE TO THREE NEEDLES SUTURES DETACHMENTS/PULL OFFS AND FRAYING? PLEASE CONFIRM. ¿ OPERATION TIME INCREASED BY 15-20 MINUTES DUE TO THREE SUTURE ATTEMPTS, THEN STAFF WERE SENT FOR ANOTHER PACKAGE OF SUTURE MATERIAL, WHICH INCLUDES WAITING TIME FOR THE SURGEON. 4. HAS LATRAN BEEN USED PROPHYLACTICALLY TO PREVENT NAUSEA AND VOMITING THAT CAN BE CAUSED BY TRANSPLANT SURGERY? ¿ LOTRAN WAS USED FOR PREVENTIVE PURPOSES, AS THE OPERATION TIME WAS EXTENDED. . THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DATE SENT TO THE FDA: 04/07/2021 CORRECTED INFORMATION: B3, D3, G1 THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE.
(B)(4). DATE SENT TO THE FDA: 3/3/2021. ADDITIONAL INFORMATION: D9, H6. H6 COMPONENT CODE: G07002 ¿ CONFORMING DEVICE. ADDITIONAL H3 INVESTIGATION SUMMARY: VISUAL INSPECTION EVALUATION WAS CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT TWO NEEDLE-SUTURES PIECES OF PRODUCT CODE W8556 WERE RECEIVED FOR EVALUATION. THE NEEDLES WERE NOTED WITH MARKS THAT APPEAR TO BE BY USE OF SURGICAL INSTRUMENT., THE SUTURE PIECES WERE OBSERVED WAVY AND A LINEAL CUT THAT APPEARS TO BE BY USE OF THE SURGICAL INSTRUMENT. THE FUNCTIONAL TEST COULD NOT BE PERFORMED DUE TO THE CONDITION OF THE SAMPLE RECEIVED. THE CONDITION OF THE SAMPLE RECEIVED INDICATES IMPROPER HANDLING OF THE DEVICE. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, THE DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. VISUAL INSPECTION AND FUNCTIONAL TEST EVALUATION WERE CONDUCTED ON THE RETURNED DEVICES. VISUAL ANALYSIS OF THE RETURNED SAMPLES DETERMINED THAT AN OPENED BOX WITH NINE UNOPENED SAMPLES OF PRODUCT CODE W8556 WERE RECEIVED FOR EVALUATION. VISUAL INSPECTION OF THE UNOPENED SAMPLES AND NO DEFECTS WERE FOUND ON THE PACKAGE. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WAS NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND AND NO DEFECTS, DAMAGE OR SPLITTING WERE OBSERVED. A FUNCTIONAL TEST WAS PERFORMED AND THE PULL FORCE WAS ABOVE THE MINIMUM REQUIREMENTS. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, THE DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED AND THE ACTUAL COMPLAINT SAMPLE WAS NOT RETURNED FOR ANALYSIS. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. THIS REPORT MAY BE BASED ON INFORMATION WHICH HAS NOT BEEN INVESTIGATED OR VERIFIED PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY ETHICON INC, OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE PRODUCT, ETHICON INC OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. DATE SENT TO THE FDA: 3/3/2021. CORRECTED INFORMATION: G1.
PRODUCT COMPLAINT # (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL REPORT, A FOLLOW-UP REPORT WILL BE FILED AS APPROPRIATE. ATTEMPTS HAVE BEEN MADE TO RETRIEVE THE DEVICE. TO DATE THE DEVICE HAS NOT BEEN RETURNED. IF THE DEVICE OR FURTHER DETAILS ARE RECEIVED AT A LATER DATE A SUPPLEMENTAL MEDWATCH WILL BE SENT. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. INVESTIGATION SUMMARY: THREE PICTURES WERE RECEIVED FOR EVALUATION. UPON TO VISUAL INSPECTION OF THE PICTURES, AN OPENED BOX AND FOUR DISPENSED NEEDLE/SUTURES PIECES WITH DAMAGED/STRESS AT THE END OF PRODUCT CODE AND LOT COULD BE OBSERVED. THE PRODUCT CODE IS DOUBLE ARMED AND NO DETACHED NEEDLES WERE OBSERVED IN THE PICTURES. AS PART OF OUR QUALITY PROCESS, THE MANUFACTURING RECORDS OF THIS LOT-SERIAL NUMBER WERE REVIEWED, AND THE MANUFACTURING STANDARDS WERE MET PRIOR TO THE RELEASE OF THIS BATCH. NO CONCLUSION COULD BE REACHED AS ON WHAT CAUSED THE REPORTED COMPLAINT, SINCE THE SAMPLE WAS NOT RETURNED FOR ANALYSIS. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, DEVICE IS VISUALLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. COMPLAINT INFORMATION WILL BE INCLUDED IN COMPLAINT TRENDING THAT IS REVIEWED ON A REGULAR BASIS TO DETERMINE IF FURTHER ACTION IS NECESSARY.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE IN 2020 AND SUTURE WAS USED. DURING THE PROCEDURE, THE SUTURE FRAYED AND GOT DETACHED FROM NEEDLE. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. NO ADDITIONAL INFORMATION WAS REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 3255 | PROLENE BLUE 1.0M 90CM W/NDL | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. | PPBESH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |