MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MONOSYN VIOLET 0 (3.5) 70CM HS26S (M); SUTURES

Model Number G0022243

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 07/06/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 2 unopened pouches.Analysis and results: there are no previous complaints of this code batch.Manufactured and distributed in the market (b)(4) units of this code batch.There are no units in stock.Diameter result conducted on the samples received is 0.421 mm in average and fulfils the requirements of the (b)(6) for this size and thread: 0.400 mm < xave < 0.499 mm.The result of the average diameter is in the low range of ep requirements for usp 0 size.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).It was reported that the thread size inside the box was not was labeled on the outside of the box.

• Brand Name: MONOSYN VIOLET 0 (3.5) 70CM HS26S (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, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 6755055
• MDR Text Key: 81439962
• Report Number: 3003639970-2017-00393
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K011395
• 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
• Report Date: 07/31/2017

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
• Device Expiration Date: 09/20/2021
• Device Model Number: G0022243
• Device Catalogue Number: G0022243
• Device Lot Number: 116382
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/12/2017
• Distributor Facility Aware Date: 07/25/2017
• Initial Date Manufacturer Received: 07/07/2017
• Initial Date FDA Received: 07/31/2017
• 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