MAUDE Adverse Event Report: B.BRAUN SURGICAL SA CATGUT PLAIN 3/0 (3) 75CM HR22; SUTURES

Model Number B0530310

Device Problem Device Issue (2379)

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

Event Date 03/14/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: review of stock: product availability in stock is reviewed and to date there are units of this product code and lot number.Quantity produced / imported: this product and batch number were manufactured in total (b)(4) units.Distributed amount: the total number of units produced were distributed in an export to a single customer in (b)(6).Background: the database of complaints were reviewed and confirmed that there are no reports related to this product code and lot number.Batch record / record lot: revision of the figure for the production batch documentation was performed and was evident that no deviation, or no alterations occurred during the process.Results for batch release results obtained for batch release, were performed in compliance with the requirements demanded for this type of suture.Analysis (s) sample (s): the received sample was subjected to a visual examination where it is evident that the suture is not the solution, losing the thread sterility; this must be due to a fault during the manufacturing process, which could not be identified at the time of product release only after a long storage time and through customer statement.Conclusions: because the sample received is out of specification, the claim as "justified" is determined.Actions: this action has already been implemented in full and on measuring the effectiveness of the measures taken; now it is closed.

Event Description

Country of complaints: (b)(6).Product has no liquid to retain their properties.Received one suture packaging closed, without liquid.

• Brand Name: CATGUT PLAIN 3/0 (3) 75CM HR22
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 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: 5760221
• MDR Text Key: 48504756
• Report Number: 2916714-2016-00509
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: CI
• PMA/PMN Number: K991223
• 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: 06/28/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0530310
• Device Catalogue Number: B0530310
• Device Lot Number: 513032
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 06/20/2016
• Date Manufacturer Received: 05/31/2016
• 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