PDS PLUS VIO 8X18IN 0 S/A CTB CR
Report
- Report Number
- 2210968-2021-12483
- Event Type
- Malfunction
- Date Received
- December 10, 2021
- Date of Event
- November 15, 2021
- Report Date
- February 9, 2022
- Manufacturer
- ETHICON INC.
- Product Code
- NEW
- UDI-DI
- 10705031218833
- PMA / PMN Number
- K061037
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
PRODUCT COMPLAINT #: (B)(4). COMPONENT CODE: (B)(4). 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. THE FOLLOWING INFORMATION WAS REQUESTED, BUT UNAVAILABLE: WHERE WAS THE NEEDLE GRASPED (SWAGE, MIDDLE, BODY) BEFORE BEING USED? PROCEDURE NAME? THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. (B)(4). A MANUFACTURING RECORD EVALUATION WAS PERFORMED FOR THE FINISHED DEVICE LOT, AND NO NON-CONFORMANCES WERE IDENTIFIED.
PRODUCT COMPLAINT # (B)(4). DATE SENT TO THE FDA: 02/09/2022. THIS IS A COMBINATION PRODUCT, AND THE EVENT HAS BEEN REVIEWED FOR BOTH THE SUTURE AND THE TRICLOSAN. THIS REPORT IS BEING SUBMITTED PURSUANT TO THE PROVISIONS OF 21 CFR, PART 803. PART 4 SUBPART B. 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 EVALUATION: A FAILED SUTURE NEEDLE, LABELED AS (B)(4), WAS SUBMITTED TO FRACTOGRAPHIC EVALUATION ON DECEMBER 16, 2021. THE COMPONENT WAS IDENTIFIED AS PRODUCT CODE PDPB750D. IT WAS REQUESTED THAT ASSESS THE FRACTURE MODE OF THE FAILURE. A FRACTURE WAS OBSERVED IN THE BODY OF THE NEEDLE. THE NEEDLE WAS RECEIVED IN TWO PIECES, ONLY ONE OF THE MATING FRACTURE SURFACES WAS EXAMINED FOR THIS EVALUATION. A SCANNING ELECTRON MICROSCOPE WAS USED TO EXAMINE THE FRACTURE SURFACES AND SURROUNDING AREA OF THE NEEDLE. THE FRACTURE SURFACES WERE EXAMINED IN MULTIPLE LOCATIONS TO DETERMINE THE FRACTURE MODE. THE EVALUATION OF (B)(4) REVEALED THE FRACTURE WAS PREDOMINANTLY COMPOSED OF MICROVOID COALESCENCE, WHICH IS EVIDENCE OF A DUCTILE FRACTURE MODE. MECHANICAL DAMAGE AND A CUP-AND-CONE SHAPED FRACTURE OBSERVED COINCIDENTAL TO THE FRACTURE PROVIDE ADDITIONAL EVIDENCE THAT THE FAILURE WAS INDUCED BY MECHANICAL DEFORMATION LEADING TO DUCTILE OVERLOAD. THIS WAS A DUCTILE FRACTURE. THE EVIDENCE OF THIS EXAMINATION INDICATES THAT THE BREAKAGE OCCURRED FROM MECHANICAL DEFORMATION, INDENTS AND SCRATCHES, DUE TO GRIPPING, BENDING AND OVERSTRESSING OF THE NEEDLE. THERE IS NO EVIDENCE OF ANY MATERIAL FLAW THAT WOULD CAUSE PREMATURE FAILURE. BASED ON THE INFORMATION CURRENTLY AVAILABLE, THE NEEDLE BREAKAGE WAS IDENTIFIED DURING THE INVESTIGATION OF THE SAMPLE RECEIVED. THIS PRODUCT ISSUE WILL BE ADDRESSED THROUGH QUALITY SYSTEM. ¿ TRADE NAME - IRGACARE®. ¿ ACTIVE INGREDIENT(S) ¿ TRICLOSAN. ¿ DOSAGE FORM ¿ SUTURE/SOLID/PARENTERAL. ¿ STRENGTH ¿ = 2360 G/M.
IT WAS REPORTED THAT A PATIENT UNDERWENT AN UNKNOWN PROCEDURE ON (B)(6) 2021 AND SUTURE WAS USED. WHEN CLOSING THE SURGICAL WOUND, A NURSE NOTICED THAT THE NEEDLE HAD BEEN BROKEN AT THE BODY PART BEFORE USE. NO PART OF THE DEVICE FELL INTO THE PATIENT. NO ADVERSE PATIENT CONSEQUENCES WERE REPORTED. ADDITIONAL INFORMATION WAS REQUESTED
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1873734 | PDS PLUS VIO 8X18IN 0 S/A CTB CR | SUTURE, SURGICAL, ABSORBABLE | NEW | ETHICON INC. | RHMAUH | 10705031218833 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown |