MAUDE Adverse Event Report: ETHICON INC. VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT; SUTURE, ABSORBABLE, SYNTHETIC

Device Problems Material Frayed (1262); Product Quality Problem (1506); Dull, Blunt (2407); Device Markings/Labelling Problem (2911)

Patient Problem Wound Dehiscence (1154)

Event Date 01/01/2023

Event Type  malfunction  

Event Description

It was reported that a patient underwent a mohs/surgical excision on an unknown date around (b)(6) 2023 and suture was used for closure.The patient was prophylaxed with a cephalosporin or clindamycin depending on allergy.As the suture material was poor quality thread, the suture frayed easily during the procedure resulting in flap dehiscence.Flaps were extensively repaired when needed, and meticulous, close detail to wound care was provided by surgeon and staff.Sutures were removed from surgical site that caused dehiscence.Importantly, these sutures had chinese characters on the box.No additional information was provided.

Manufacturer Narrative

Product complaint # :(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 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.H6 component code: g07002 device not returned.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 single complaint was reported with multiple events.There are no additional details regarding the additional patient events.Attempts are being made to obtain the information.To date no response has been provided.If further details are received at a later date a supplemental medwatch will be sent.Additional information: d4, h4 - the actual device product code and batch number associated with this event is not known.The possible product code and batch numbers are reported as follows: j493g lot # tbmkmq, expiration date: jan/31/2028 date of mfg.: feb/21/2023.J497g lot # temepe, expiration date: apr/30/2028 date of mfg.: may/11/2023.J496g lot # unknown.In addition, a review of the manufacturing record evaluation for the possible batch number was performed for the finished device lot, and no non-conformances were identified.Additional information was requested the following was received: could you tell me if there was a prescription for steroids or antibiotics for the patient's recovery? if yes, please provide medication name, route and dose.Yes, mohs and surgical excision patient treated during (b)(6) 2023 experienced inflammatory and infectious responses following closure.Treated with oral antibiotics.Preoperatively prophylaxed with a cephalasporin or clindamycin depending on allergy.Presented with inflammatory and subsequent infectious responses limited to the suture area of the skin, as opposed to typical wound infections which display uniform wound erythema, edema, tenderness and exudate.Also, as the suture material was poor quality thread, these sutures frayed easily during procedures resulting in flap dehiscence.Cultures of these wounds grew pseudomonas aeruginosa, mostly susceptible to ciprofloxacin which was prescribed as indicated.I do not believe any of such patients who had a culture from the dehisced or suture created infections i am writing about, had wound cultures positive for staphyloccocus aureus which is very skewed.About ¼ of the patients needed prednisone for mixed courses to eradicate the inflammatory suture response.The patient may had one or several prior surgical procedures in our offices free of these reactions.Was there any medical or surgical intervention performed (product removed; re-operation; re-suturing; re-closure; drainage)? if so, please specify.Yes, all affected patients needed surgical intervention in addition to antibiotic intervention.Wounds were cultured, debrided, drained, re-sutured, flaps were extensively repaired when needed, and meticulous, close detail to wound care was provided by myself and my staff.Vicryl sutures were removed from every surgical site these sutures caused dehiscence, inflammation, and /or infection to.What is the identified quality issue with specific ethicon sutures? for several weeks, the noted vicryl sutures had been fraying easily.This revealed itself by me having to use 2 or 3 vicryl sutures to close a case that would normally require one suture.Our instruments were changed and or sharpened but they were not the culprit.In addition, the needles on these specific sutures were poor quality and dull, with little cutting ability.Knots did not hold.Routine excisions developed infection and inflammation strictly at suture placement sites with normal skin gaps in between suture placement.Defects closed with flaps that were sufficiently undermined and meticulously sutured dehisced in days.Importantly, all of these poor quality ethicon vicryl sutures had chinese characters on the boxes.I have never seen that before on any ethicon sutures i have used in my offices.I was told the sutures came from our medical supply company who purchased them from a different supply company.There are no sutures on either websites that i scrupulously examined displaying chinese characters.My nurse alerted me to do this after we realized the cluster effect of surgical complications and the concomitant poor quality ethicon vicryl sutures i was supplied with.I have a video of the suture in question comparing it to other high grade ethicon sutures which came from boxes devoid of chinese lettering.What are the resulting complications from these specific ethicon sutures? noted above.What is the total number of products involved in this event? i do not know the exact number of product involved in this event.I can account for poor quality sutures, but i believe it is many more than that unfortunately.Most of these sutures were returned to our medical supply company.Have any of these events been previously reported to ethicon? if so, provide the respective reference number(s).Not that i know of.This is the first time i have experienced a cluster of wound infections and poor surgical outcomes due to poor quality ethicon sutures in my 25 year plus career as a dermatologic surgeon.Please provide the product code and lot number for all the products involved in this complaint: there were multiple.The ones still in my possession are: j493g, lot tbmkmq j496g, lot unrecognizable as in chinese character.Device return status.Please document the shipment tracking number: i do not have this information.Related medwatch reports: 2210968-2023-07207.

• Brand Name: VICRYL POLYGLACTIN 910 SUTURE UNKNOWN PRODUCT
• Type of Device: SUTURE, ABSORBABLE, SYNTHETIC
• Manufacturer (Section D): ETHICON INC.; 1000 route 202; raritan NJ 08869
• Manufacturer (Section G): ETHICON INC.-JUAREZ; calle durango #2751; ciudad juarez 32575 ; MX 32575
• Manufacturer Contact: elba bello ; 1000 route 202; raritan, NJ 08869 ; 9083863534
• MDR Report Key: 17850697
• MDR Text Key: 324673715
• Report Number: 2210968-2023-07219
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K022269
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 10/02/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 09/04/2023
• Initial Date FDA Received: 10/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1