MAUDE Adverse Event Report: B.BRAUN SURGICAL SA OPTILENE 5/0 (1) 45CM DSMP13 (M) RCP; SUTURES

Model Number C3090619

Device Problem Loose or Intermittent Connection (1371)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 33 unopened racepacks.Analysis and results: there are no previous complaints of the same code-batch.Manufactured and distributed in the market 504 units of this code-batch.There are no units in stock.Tested the needle attachment of all samples received and the results fulfill theoem requirements.0.62 kgf in average and 0.36 kgf in minimum (ep requirements: 0.23 kgf in average and 0.11 kgf in minimum) reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Final conclusion: although the results of the samples received fulfill the oem specifications, note of this incident is taken 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.

Event Description

Country of complaint: (b)(6).The suture detached from the needle without any pressure or traction.It happened when the surgeon took the first bite when he intended to suture the eyelid intracutaneously.

• Brand Name: OPTILENE 5/0 (1) 45CM DSMP13 (M) RCP
• 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, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7617292
• MDR Text Key: 111719644
• Report Number: 3003639970-2018-00358
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: NO
• 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
• Type of Report: Initial,Followup
• Report Date: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/22/2022
• Device Model Number: C3090619
• Device Catalogue Number: C3090619
• Device Lot Number: 117473
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/05/2018
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 06/01/2018
• Date Manufacturer Received: 05/23/2018
• 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
• Patient Weight: 75