PROLENE BLUE 0.7M 60CM W/NDL
Report
- Report Number
- 2210968-2022-06420
- Event Type
- Malfunction
- Date Received
- August 9, 2022
- Report Date
- November 18, 2022
- Manufacturer
- ETHICON INC.
- Product Code
- GAW
- PMA / PMN Number
- K133356
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TW
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
(B)(4). 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, 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. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: WHAT DO YOU MEAN BY "IS EASY TO DISCONNECT AT MEDDLE OF THREAD"? PLEASE PROVIDE MORE DETAILS, WHAT WAS THE EXACT ISSUE? PLEASE CLARIFY. MEDDLE OF THREAD IS EASILY BROKE. DID THE SUTURE GOT SEPARATED FROM THE NEEDLE? NO. COULD YOU PLEASE CLARIFY HOW MANY DEVICES PRESENT THIS ISSUE? TWO. WHAT IS THE LOT NUMBER? SABCUB. DEVICE RETURN FOLLOW UP. DEVICE WILL BE RETURNED. ASSOCIATED EVENTS SUBMITTED VIA MW# 2210968-2022-06419 AND THIS REPORT.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 08/31/2022 H6 COMPONENT CODE: G07002 - DEVICE NOT RETURNED 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. ADDITIONAL INFORMATION WAS REQUESTED AND THE FOLLOWING WAS OBTAINED: THE FOLLOWING ADDITIONAL INFORMATION WAS RECEIVED FROM THE SALES-REP VERBALLY ON AUG 22, 2022: BECAUSE OF EASILY BREAKAGE OF SUTURE, DOCTOR WOULDN'T USE THIS LOT# OF PRODUCTS, THEN 24 EA W8704 WILL BE RETURNED AS COMPLAINT PRODUCT.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/15/2022 ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: THE PRODUCT RETURNED (W8704, LOT# RMBAPE , SABCAH) BELONGS TO THIS COMPLAINT. SALES PROVIDES THE WRONG IMPACT PRODUCT INFORMATION (W8704, LOT# SABCUB). PLEASE REVISE THE IMPACT PRODUCT INFORMATION. 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. REPORTED EVENTS: MW# 2210968-2022-06419. PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/15/2022. 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.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 11/16/2022. 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, 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. THE DEVICE UPON WHICH THIS MEDWATCH IS BASED HAS BEEN RECEIVED, HOWEVER, THE PRODUCT EVALUATION IS NOT YET COMPLETE. ANY FURTHER INFORMATION DERIVED FROM THE EVALUATION WILL BE SUBMITTED IN A SUPPLEMENTAL 3500A FORM. THE FOLLOWING ADDITIONAL INFORMATION WAS REQUESTED: WE RECEIVED PRODUCT RETURN FOR LOTS SABCUB, RMBAPE, AND SABCAH. HOWEVER, ADDITIONAL INFORMATION STATES THAT LOT SABCUB DOES NOT BELONG TO THIS COMPLAINT. WAS LOT SABCUB RETURNED IN ERROR? ADDITIONAL INFORMATION WAS REQUESTED, THE FOLLOWING WAS OBTAINED: SORRY FOR THE ERROR INFORMATION, AFTER CHECKING WITH SALES VERBALLY, LOT# RMBAPE , SABCAH , SABCUB ALL BELONGS TO THIS PRODUCT COMPLAINT. SABCAH 2EA; RMBAPE 6EA; SABCUB 16EA. EVENTS REPORTED VIA MW# 2210968-2022-06419, MW# 2210968-2022-06420, AND MW# 2210968-2022-09483.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 10/18/2022. H6 COMPONENT CODE: G07002 NO DEVICE PROBLEM FOUND. H3 INVESTIGATIONAL SUMMARY: THE PRODUCT WAS RETURNED TO ETHICON FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TEST EVALUATION WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE DETERMINED THAT SIXTEEN PACKETS THAT PERTAINS TO THE PRODUCT CODE W8704 WERE RETURNED TO ETHICON FOR ANALYSIS WITH THE PACKAGING CLOSED. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKETS. AS PER THE SAMPLING PLAN, A VISUAL INSPECTION WAS PERFORMED ON THIRTEEN SAMPLES, AND NO DEFECTS WERE FOUND ON THE PACKAGES. THE SAMPLES WERE OPENED, AND THE SWAGE AND ATTACHMENT AREA WERE NOTED TO BE AS EXPECTED. THE SUTURES WERE DISPENSED WITHOUT PROBLEMS AND EXAMINED ALONG THE STRAND AND NO DEFECTS, DAMAGE, OR SUTURE BREAKAGE WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED USING AN INSTRON EQUIPMENT AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH BATCH IS RANDOMLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. THE FOLLOWING INFORMATION WAS REQUESTED: OUR ANALYSIS LAB RECEIVED THE WRONG PRODUCT WITH REFERENCE TO THIS COMPLAINT, THE FOLLOWING PRODUCT WAS RECEIVED: - PRODUCT CODE: W8704. - PRODUCT LOT #: RMBAPE AND SABCAH. 1. COULD YOU PLEASE CLARIFY IF WRONG DEVICE BELONGS TO THIS COMPLAINT? 2. IF NOT, COULD YOU PLEASE CLARIFY IF THE WRONG RECEIVED PRODUCT BELONGS TO A DIFFERENT COMPLAINT? IF SO, CAN YOU PLEASE PROVIDE THE COMPLAINT NUMBER. 3. IF THE DEVICE WAS NOT REPORTED BEFORE, PLEASE PROVIDE MORE DETAILS OF DEVICE MALFUNCTION. 4. IF THE PRODUCT DOESN¿T BELONG TO ANY COMPLAINT, PLEASE LET US KNOW SO WE CAN DISCARD IT OR ADVISE IF THE PRODUCT IS REQUIRED TO BE RETURNED. 5. IF YOU HAVE THE CORRECT COMPLAINT PRODUCT IN YOUR POSSESSION, PLEASE FORWARD THE PRODUCT TO ETHICON AS SOON AS POSSIBLE. IF YOU HAVE ALREADY SENT THE PRODUCT TO ETHICON, PLEASE REPLY TO [email protected] WITH THE UPS, DHL OR FEDEX TRACKER NUMBER. 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. REPORTED EVENTS: MW# 2210968-2022-06419 AND MW# 2210968-2022-06420.
PRODUCT COMPLAINT (B)(4). DATE SENT TO THE FDA: 11/18/2022. H6 COMPONENT CODE: G07002 - NO DEVICE PROBLEM FOUND. 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. H3 INVESTIGATION SUMMARY: THE PRODUCT WAS RETURNED FOR EVALUATION. VISUAL INSPECTION AND FUNCTIONAL TESTING WERE CONDUCTED ON THE RETURNED DEVICE. VISUAL ANALYSIS OF THE RETURNED SAMPLE REVEALED THAT TWO PACKETS THAT PERTAIN TO PRODUCT CODE W8704, LOT SABCAH WERE RETURNED FOR ANALYSIS WITH THE PACKAGING CLOSED. UPON INITIAL INSPECTION, OF THE SAMPLES, NO EXTERNAL DAMAGES WERE OBSERVED ON THE PACKET. IN ORDER TO EVALUATE THE CONDITIONS OF THE RETURNED SAMPLES, THE TWO PACKETS WERE OPENED, AND NO DEFECTS WERE DETECTED. 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 SUTURE BREAKAGE WERE NOTED. A FUNCTIONAL TEST WAS PERFORMED USING INSTRON EQUIPMENT AND THE TENSILE STRENGTH FORCE WAS ABOVE THE MINIMUM REQUIREMENT. THE EVENT DESCRIBED COULD NOT BE CONFIRMED AS THE DEVICE PERFORMED WITHOUT ANY DEFECT NOTED. IT SHOULD BE NOTED THAT AS PART OF OUR QUALITY PROCESS, EACH BATCH IS RANDOMLY INSPECTED AND FUNCTIONALLY TESTED DURING MANUFACTURING TO ENSURE THE DEVICE MEETS THE REQUIRED SPECIFICATIONS PRIOR TO SHIPMENT. THERE MAY HAVE BEEN OTHER CIRCUMSTANCES OR ISSUES THAT OCCURRED DURING THE USE OF THE DEVICE THAT WE WERE UNABLE TO DUPLICATE DURING OUR LABORATORY ANALYSIS. ADDITIONAL COMPLAINT INFORMATION MONITORING FOR POTENTIAL SAFETY SIGNALS IS CONDUCTED THROUGH COMPLAINT TRENDING AS PART OF POST-MARKET SURVEILLANCE. A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE BATCH AND NO NON-CONFORMANCES WERE IDENTIFIED.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON AN UNKNOWN DATE IN 2022 AND THE SUTURE WAS USED. DURING SURGERY, THE SUTURE EASILY BROKE. THERE WERE NO ADVERSE PATIENT CONSEQUENCES REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1941570 | PROLENE BLUE 0.7M 60CM W/NDL | SUTURE, NONABSORBABLE, SYNTHETIC, POLYPROPYLENE | GAW | ETHICON INC. | SABCAH |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |