MCKESSON POLYGLYCOLIC ACID 5-0
Report
- Report Number
- MW5176521
- Event Type
- Injury
- Date Received
- September 24, 2025
- Date of Event
- September 15, 2025
- Report Date
- January 7, 2026
- Manufacturer
- COVIDIEN
- Product Code
- GAM
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Voluntary report
- Reporter Location
- OR, US
- Reporter Occupation
- PATIENT
- Health Professional
- N
Narratives
PATIENT INFORMATION: I, (B)(6), AM A PARTICIPANT IN GROUP K OF THE HARBOR STUDY AT (B)(6). PRIMARY INVESTIGATOR (WAS NOT PRESENT ON-SITE DAY OF INCIDENT): (B)(6) PATIENT PROBLEM / ADVERSE EVENT(S): BIOPSY & DEVICE MALFUNCTION: - DURING A SKIN BIOPSY, THE NURSE PERFORMING THE PROCEDURE, (B)(6) SAID THAT THE SUTURE NEEDLE BROKE. THE OTHER NURSING STAFF IN THE ROOM ALSO REFERRED TO WHAT HAPPENED AS A SUTURE NEEDLE BREAKING. ("DID THE NEEDLE BREAK?" "YEAH, IT BROKE.") THIS IS WHAT THE STUDY SITE SAID REGARDING THE ADVERSE EVENT AND CATASTROPHIC EQUIPMENT FAILURE: THE SUTURE USED FOR YOU WAS A 5-0 POLYGLYCOLIC ACID, P-13, 3/8 13MM NEEDLE, LOT # D5F3221FY. THIS LOT # HAS NOT BEEN RECALLED AND HAS NOT EXPIRED. HOWEVER, THERE HAVE BEEN RECALLS ON MEDICAL SUTURE NEEDLES IN RECENT YEARS, PRIMARILY DUE TO ISSUES LIKE NEEDLE BREAKAGE, SHARPNESS DEFECTS, CONTAMINATION RISKS, OR MANUFACTURING QUALITY CONTROL PROBLEMS. AFTER A QUICK SEARCH, I FOUND SOME SPECIFIC RECALLS FOR SUTURE NEEDLES ARE LESS FREQUENTLY DETAILED COMPARED TO OTHER MEDICAL DEVICES. BELOW IS A SUMMARY BASED ON THE AVAILABLE DATA THAT I WAS ABLE TO DIG UP ONLINE. WE ARE STILL WORKING WITH THE MANUFACTURER AND HAVE SUBMITTED PICTURES FOR THEM TO REVIEW. (B)(6) SUBMITTED SOMETHING EARLIER THIS WEEK AND FOLLOWED UP ON IT AGAIN TODAY. ETHICON, INC. VICRYL (POLYGLACTIN 910) SUTURE RECALL (2024): A CLASS 2 RECALL WAS ISSUED FOR COATED VICRYL POLYGLACTIN 910 SUTURES (LOT # QP2AJM) DUE TO NEEDLE PULL-OFF AND SUTURE DEGRADATION ISSUES. THE RECALL, INITIATED ON SEPTEMBER 25, 2024, AND POSTED ON NOVEMBER 7, 2024, NOTED COMPLAINTS ABOUT NEEDLE DETACHMENT AND DEGRADED SUTURES IN THE PACKAGING. WHILE THIS DOESN'T DIRECTLY MATCH YOUR SPECIFIED LOT (D5F3221FY), IT INVOLVES A SIMILAR POLYGLYCOLIC ACID-BASED SUTURE, INDICATING POTENTIAL MANUFACTURING ISSUES IN RELATED PRODUCTS. ETHICON, LLC PROLENE POLYPROPYLENE & ETHIBOND EXCEL POLYESTER SUTURE RECALL: THIS RECALL, NOTED BY (B)(6), INVOLVED SUTURES. BIOPSY & DEVICE MALFUNCTION CONT.: - I EXPERIENCED SEVERE UNCONTROLLED PAIN DURING AND AFTER THE PROCEDURE. LIDOCAINE WAS ADMINISTERED, BUT IT WAS INSUFFICIENT DUE TO MEDICATION CONFLICTS ALREADY DOCUMENTED IN MY CHART (ADVIL CAUSING UNCONTROLLED NOSEBLEEDS, TYLENOL IN LARGE DOSES CAUSING GUM BLEEDING, LOW DOSE NATREXONE RENDERING ANY KIND OF OPIOIDS INEFFECTIVE). - THE CLINIC KNEW IN ADVANCE THAT COMMON ANESTHETICS WOULD NOT BE EFFECTIVE FOR ME BUT DID NOT PROVIDE VIABLE ALTERNATIVES. PRIVACY VIOLATION / STAFF MISCONDUCT: - A NURSE PUSHED THROUGH THE EXAM ROOM DOOR AFTER I SAID "NO" AND PHYSICALLY PUSHED BACK. OTHER HARMS: - THE TRAVEL CONCIERGE SERVICE ARRANGED BY THE SITE WAS INADEQUATE AND WORSENED MY SYMPTOMS BY CAUSING EXTREME STRESS. B. SUSPECT DEVICE BROKEN SUTURE NEEDLE DEVICE FAILURE: NEEDLE BROKE DURING PROCEDURE, CAUSING PAIN AND NEED TO USE A SCALPEL TO EXCISE IT FROM THE BIOPSY SITE. C. REPORTER INFORMATION REPORTER: (B)(6) NOTIFICATIONS: I HAVE CALLED THE SPONSOR PATIENT ADVOCATE WITHIN AN HOUR OF THE CATASTROPHIC INSTRUMENT FAILURE AND BCC'ED IRB ON SEVERAL WRITTEN COMPLAINTS DETAILING THE INCIDENT. D. OUTCOMES ATTRIBUTED TO THE ADVERSE EVENT -SERIOUS INJURY: SEVERE UNCONTROLLED PAIN AND ONGOING COMPLICATIONS. HAVE VISITED URGENT CARE. LOSS OF ABILITY TO WORK. IMPACTING ACTIVITIES OF DAILY LIVING. - INCOMPLETE AND INADEQUATE DISCLOSURE OF RISKS WITH INFORMED CONSENT. EVEN MY WISDOM TEETH REMOVAL AT AGE 12 WARNED ME THAT I COULD DIE - A BROKEN NEEDLE OR OTHER SUTURE EQUIPMENT FAILURE WAS NOT ADEQUATELY OR PROPERLY LISTED AS A POSSIBLE EVENT TO CONSENTING TO A SKIN BIOPSY. THIS IS MY SECOND INFORMED CONSENT CONCERN WITH THIS STUDY - THE FIRST WAS WITH HOW THE CONCIERGE SERVICE USES THEIR OWN DEBIT CARD TO REIMBURSE. DUE TO HAVING AN MRI AS PART OF THE CLINICAL TRIAL INTAKE AND MY LOSS OF TRUST AND CONFIDENCE IN THE PROVIDERS AT (B)(6), I REQUESTED THE THIRD-PARTY IMAGING CENTER CONFIRM THAT THERE WAS NO METAL LEFT FROM THE ADVERSE EVENT/CATASTROPHIC EQUIPMENT FAILURE.
ADDITIONAL INFORMATION RECEIVED ON 12/31/2025 FOR REPORT MW5176521. THIS SUBMISSION PROVIDES SUPPLEMENTAL INFORMATION RELATED TO A PRIOR FDA MEDWATCH REPORT (ACCESS NUMBER MW5176521) THAT I FILED ON SEPT. 19, 2025. SINCE THAT SUBMISSION, I RECEIVED ADDITIONAL DOCUMENTATION FROM THE DISTRIBUTOR ((B)(4)) AND THE MANUFACTURER (MEDTRONIC MEDICAL SURGICAL) REGARDING THE SAME EVENT INVOLVING A BROKEN SUTURE NEEDLE DURING A SKIN BIOPSY PERFORMED IN A CLINICAL STUDY. THE ADDITIONAL INFORMATION CONTAINS GOOGLE DRIVE LINKS THAT CONTAIN CORRESPONDENCE WHICH CONFIRMS THAT THE EVENT WAS LOGGED AS A DEVICE COMPLAINT, ATTRIBUTED TO A SPECIFIC SUTURE PRODUCT AND LOT NUMBER (SJ493GX, 5-0 POLYGLACTIN SUTURE WITH P-13 NEEDLE, LOT #D5F3221FY), ROUTED THROUGH MDR/MEDWATCH HANDLING, AND REMAINS OPEN PENDING MANUFACTURER CLOSEOUT. THIS INFORMATION IS PROVIDED TO SUPPLEMENT MEDWATCH REPORT MW5176521 AND TO ENSURE FDA HAS A COMPLETE AND CURRENT RECORD. PLEASE FIND LINKS TO GOOGLE DRIVE PDFS EMAIL FROM (B)(4) 12/26/2025. (B)(4). EMAIL FROM MEDTRONIC 10/31/2025. (B)(4).
ADDITIONAL INFORMATION RECEIVED ON 10/22/2025 FOR REPORT MW5176521 TO UPDATE THE EVENT. THIS REPORT SUPPLEMENTS MY PRIOR MEDWATCH SUBMISSION FILED SEPT. 19, 2025, REGARDING A BIOPSY-RELATED ADVERSE EVENT DURING SCREENING FOR THE (B)(4) CLINICAL TRIAL. ON (B)(6) 2025, DURING CLOSURE OF A SKIN BIOPSY SITE, A NEEDLE PULL-OFF OF THE SUTURE LINE OCCURRED. THE NEEDLE DETACHED FROM THE SUTURE, PROLONGING THE PROCEDURE AND CAUSING SEVERE PAIN, BURNING, AND RADIATING DISCOMFORT. ADDITIONAL LIDOCAINE WAS ADMINISTERED. THE EVENT PRODUCED NAUSEA, SWEATING, AND SHAKING. ON SEPT. 18, 2025, THE CLINICAL SITE INFORMED ME OF THE SUTURE SPECIFICATIONS. THE SUTURE USED FOR YOU WAS A 5-0 POLYGLYCOLIC ACID, P-13, 3/8 13 MM NEEDLE, LOT # D5F3221FY. THIS LOT # HAS NOT BEEN RECALLED AND HAS NOT EXPIRED. THE CLINIC DESCRIBED THE INCIDENT AS "NEEDLE PULL-OFF OF THE SUTURE LINE." A SIMILAR DEFECT TYPE WAS CITED IN FDA CLASS II RECALL Z-3071-2024 (ETHICON COATED VICRYL POLYGLACTIN 910, LOT QP2AJM, INITIATED SEPT. 25, 2024, POSTED NOV. 7, 2024) INVOLVING NEEDLE DETACHMENT AND SUTURE DEGRADATION IN A RELATED POLYMER FAMILY. THAT SAME DAY IN THE SAME EMAIL, THE SITE CONFIRMED THEY WERE CONTACTING THE MANUFACTURER AND SUBMITTING PHOTOS OF THE DEFECTIVE SUTURE FOR REVIEW. AFTER THE ADVERSE EVENT, I SOUGHT MEDICAL EVALUATION IN (B)(6), WHERE I LIVE. ON (B)(6) 2025, AN URGENT-CARE PROVIDER EXAMINED THE WOUND, DOCUMENTED REDNESS, SWELLING, AND TENDERNESS, AND PRESCRIBED TOPICAL MUPIROCIN OINTMENT TO APPLY TWICE DAILY. THE PROVIDER VERBALLY EXPRESSED CONCERN THAT ANTIBIOTICS HAD NOT BEEN PRESCRIBED IMMEDIATELY AFTER THE BIOPSY. FROM (B)(6), I APPLIED MUPIROCIN TWICE DAILY, USED HYPOCHLOROUS SPRAY, STERILE GAUZE, AND PRACTICED PROPER HAND WASHING. THE WOUND EDGE WAS BRIGHT RED, WITH REDNESS EXTENDING TWO TO THREE MILLIMETERS AROUND THE INCISION, AND THE AREA STAYED TENDER AND HOT TO THE TOUCH THROUGHOUT THIS PERIOD. ON (B)(6) 2025, GREEN DISCHARGE WAS NOTED ON THE BANDAGE AND REPORTED TO THE PRIMARY INVESTIGATOR BY EMAIL. PAIN PREVENTED SLEEP UNTIL THE SUTURE WAS REMOVED, WHICH WAS ON (B)(6) 2025. I DISCONTINUED THE TOPICAL ANTIBIOTIC ON (B)(6) 2025, FOLLOWING THE URGENT-CARE PROVIDER'S INSTRUCTIONS, WHICH INCLUDED CONTINUED DAILY WOUND MONITORING AND TEMPERATURE CHECKS AT HOME. WHEN REDNESS, TENDERNESS, AND WARMTH PERSISTED, I RESUMED MUPIROCIN WITHIN ONE TO TWO DAYS UNDER THE DIRECTION OF THE PRIMARY INVESTIGATOR VIA EMAIL GUIDANCE. ON (B)(6) 2025, A SECOND (B)(6) PROVIDER EVALUATED THE WOUND AND PRESCRIBED ORAL KEFLEX (CEPHALEXIN) DUE TO CONTINUED INFLAMMATION AND HEAT AT THE SITE. AFTER STARTING KEFLEX, REDNESS AND WARMTH AT THE WOUND EDGE IMPROVED, AND PAIN GRADUALLY LESSENED FOLLOWING COMPLETION OF THE ORAL ANTIBIOTIC COURSE. I CONTINUED TWICE-DAILY BANDAGE CHANGES AND THE TOPICAL ANTIBIOTIC. I REGULARLY SENT WOUND-SITE UPDATES AND PHOTOGRAPHS TO THE PRIMARY INVESTIGATOR VIA EMAIL. ON (B)(6) 2025, I WAS INFORMED DURING A TELEMEDICINE APPOINTMENT WITH THE SITE'S PRINCIPAL INVESTIGATOR THAT I WOULD BE REMOVED FROM STUDY PARTICIPATION. NO FURTHER STUDY ACTIVITIES WERE SCHEDULED FOLLOWING THAT CALL. I AM SUBMITTING THIS ADDENDUM TO ENSURE THE FDA'S POST-MARKETING SAFETY DATABASE REFLECTS (1) THE CONFIRMED SUTURE INFORMATION PROVIDED SEPT. 18, (2) MY CONTINUED, MEDICALLY DIRECTED WOUND CARE AND FOLLOW-UP, AND (3) MY REMOVAL FROM STUDY PARTICIPATION AFTER REPORTING THE ADVERSE EVENT. THESE DETAILS MAY ASSIST FDA REVIEWERS IN LINKING THIS FOLLOW-UP TO MY ORIGINAL SEPT. 19, 2025, REPORT AND IN EVALUATING ANY RELATED MANUFACTURING OR SITE-LEVEL COMPLIANCE ISSUES. SUPPORTING DOCUMENTATION--INCLUDING CLINIC CORRESPONDENCE, WOUND PHOTOGRAPHS, URGENT-CARE VISIT SUMMARIES, AND EMAILS WITH THE PRIMARY INVESTIGATOR--CAN BE PROVIDED TO FDA UPON REQUEST.
ADDITIONAL INFORMATION RECEIVED FROM THE REPORTER ON 01072026 FOR REPORT NUMBER MW5176521 TO CORRECT THE MANUFACTURER. THE EVENT WAS LOGGED BY THE DISTRIBUTOR (B)(4) AS A DEVICE COMPLAINT AND ROUTED INTERNALLY THROUGH MDR / MEDWATCH HANDLING; THE MANUFACTURER (MEDTRONIC / COVIDIEN) HAS NOT ISSUED A CLOSEOUT RESPONSE AS OF OCT. 2025.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 278899 | MCKESSON POLYGLYCOLIC ACID 5-0 | SUTURE, ABSORBABLE, SYNTHETIC, POLYGLYCOLIC ACID | GAM | COVIDIEN | SJ493GX | D5F3221FY |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 40 YR | Female | Disability| O| R | ADDERALL 10 MG.| ATIVAN 0.5 MG PRN.| BENADRYL PRN.| CETIRIZINE 5 MG 2X/DAY.| CROMOLYN SODIUM (80 ML/DAY OR 16 AMPULES).| CYMBALTA 60 MG.| DOXEPIN 40 MG.| EPINEPHRINE PRN.| FAMOTIDINE 20 MG 2X/DAY.| GUMMY WOMEN'S MULTIVITAMIN.| KETOTIFEN 2 MG.| KYLEENA IUD 14 MCG/DAY.| LOS DOSE NALTREXONE 4.5 MG.| SINGULAIR 10 MG.| SUMATRIPTAN 50 MG PRN.| SUMATRIPTAN 50 MG PRN.| TIRZEPATIDE 2.5 MG.| TYLENOL AS NEEDED | WAS ON AYVAKIT 25 MG UNTIL (B)(6) 2025. DISCONTINUED TO BE PART OF THE CLINICAL TRIAL.| ZANTAC FAMOTIDINE 20 MG TABLET X 2 DAY | ZOFRAN AS NEEDED | ZYRTEC CETIRIZINE 5 MG TABLET X 2 |