MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 3/0 (2) 45CM DSMP24 (M) RCP; OTHER SUTURE

Model Number C3090656

Device Problems Break (1069); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 2 unopened race-packs to analyze.Analysis and results: there are no previous complaints of the same code-batch.We have received 4 cases from the same customer involving this code-batch.We manufactured and distributed in the market (b)(4) units of this code batch.There are no units in our stock.We have tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep).Additionally, needle attachment strength test has been conducted on the samples received in order to discard a faulty needle attachment during manufacturing process that could cause splitting/fraying in the thread.The needle attachment strength results fulfil the requirements of the european pharmacopoeia (ep).We have not found splitting on thread surface on the closed samples received before and after performing tests.Review of the batch manufacturing record showed there are no incidences related to this issue and the results during the process fulfilled usp/ep and b.Braun surgical requirements.Furthermore, we have reviewed the complaint history record of several products manufactured with the same thread raw material batch as the used in this product, and there are no previous complaints in any of them.As indicated in the instructions for use of the product, when working with optilene suture material, great care should be taken to avoid any crushing or crimping damage of the monofilament by instruments such as forceps or needle holders.According to the results of the samples tested and the batch manufacturing record review, the product complies with our specifications and also fulfill usp/ep requirements.Therefore we do not see any manufacturing fault or material defect that could have caused the incidence.Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.

Event Description

It was reported that there was an issue with the suture.During intra-cutaneous suture removal, the suture broke into the wound and became frayed.It was difficult to remove the 2 knots and forceps and scalpel blade were used.It was noted that surgery was delayed for more than 15 minutes but there was no patient harm.Additional information has been requested.

• Brand Name: OPTILENE 3/0 (2) 45CM DSMP24 (M) RCP
• Type of Device: OTHER SUTURE
• 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, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 8303017
• MDR Text Key: 134973711
• Report Number: 3003639970-2019-00073
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: HU
• PMA/PMN Number: K133890
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/28/2023
• Device Model Number: C3090656
• Device Catalogue Number: C3090656
• Device Lot Number: 118352V030
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/21/2019
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 01/18/2019
• Date Manufacturer Received: 01/10/2019
• 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
• Patient Age: 56 YR
• Patient Weight: 78