MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SAFIL QUI+ UNDY 3/0 (2) 70CM DS24 (M); SUTURES

Model Number C1046235

Device Problems Degraded (1153); Naturally Worn (2988)

Patient Problems Wound Dehiscence (1154); Post Operative Wound Infection (2446)

Event Date 08/20/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of compliant: (b)(6).It was reported that the products were used for closure of episiotomy,infection was found after used, doctor investigated that the infection was due to suture can not be absorbed.The wound got better once the suture was removed.

Manufacturer Narrative

Samples received: 134 unopened pouches.Analysis and results: there are no previous complaints of this batch.Three cases received from the same customers involving different patients.We manufactured and distributed in the market (b)(4) units of the involved batch.There are no units in stock in b.Braun surgical warehouse.Tightness test to the closed samples received has been performed and the units are tight.We have conducted degradation tests with the samples received.Degradation test results conducted on the sample received fulfils b.Braun surgical requirements.In the degradation test, threads are introduced in (b)(4) for 7 days.After this period the knot pull tensile strength of the threads are tested.The results for the samples received are 0.55 kgf in minimum and 0.68 kgf in maximum.B.Braun surgical requirement are between 0.29 kgf and 1.30 kgf.These values are the usual ones for this thread and size.Sterilization method using ethylene oxide has been validated for this product.Safil quick biocompatibility has been tested according iso (b)(4) series in numerous experiments and the harmless of safil quick was proved.As stated in the instructions for use of the product: mode of action: suture materials are used primarily for adaptation of the wound edges to render possible and undisturbed wound healing.Upon implantation of safil® quick sutures a mild inflammatory reaction may occur, which is typical of an endogenous reaction to foreign bodies.As time passes, the suture material is encapsulated by fibrous connective tissue.Finally, safil ® quick is hydrolyzed to glycolic acid and metabolized by the body without causing any enduring alterations of the implantation site.Absorption begins with a decline in tensile strength followed by a loss of mass.Subcutaneous and intramuscular implantation studies of safil® quick show that at 5 days postimplantation approximately 50% of the initial tensile strength remains and 10 to 14 days postimplantation almost all of the initial tensile strength is lost.Most of the suture mass absorption of safil® quick takes place after approximately 42 days, except sizes larger than usp2/0 which are essentially absorbed after 56 days.Contra-indications: usage of safil® quick is contraindicated for applications where extended approximation of tissues under stress or where long term wound support of closure is required.It is also contraindicated for use in cardiovascular tissues and neurological tissues.The use of safil® quick may not be advised in case of elderly, malnourished or debilitated patients, or in patients suffering from diseases or conditions which delay the wound healing process.Notes / warnings / precautionary measures: users should be familiar with the surgical procedures and techniques involving absorbable sutures when using safil® quick.The risk of wound dehiscence may vary depending upon the site of application and the type of material used.Acceptable surgical practice should be followed for the management of contaminated or infected wounds.Skin sutures which remain in place longer than 7 days may cause localized irritation and should be snipped off or removed as indicated.Consideration should be taken in the use of absorbable sutures in tissues with poor blood supply as suture extrusion and delayed absorption may occur.Subcuticular sutures should be placed as deeply as possible to minimize the erythema and induration normally associated with the absorption process.Side effects: as for every other suture material, prolonged contact with salt solutions such as urine and bile can lead to lithiasis.The following side effects may be associated with the use of this product: transitory local irritation, transient inflammatory foreign body reaction, enhanced bacterial infectivity, wound dehiscence and granulation.Clinical comments: there are three different episiotomies which can be made: midline, mediolateral and lateral.In regards to the lateral type, this is almost not performed due to the high complication rate.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: SAFIL QUI+ UNDY 3/0 (2) 70CM DS24 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 6856335
• MDR Text Key: 85757537
• Report Number: 3003639970-2017-00454
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K031286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/11/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C1046235
• Device Catalogue Number: C1046235
• Device Lot Number: 116214
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 09/07/2017
• Date Manufacturer Received: 08/28/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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
• Patient Outcome(s): Other