MAUDE Adverse Event Report: B.BRAUN SURGICAL SA CATGUT CHROM 4/0 (2) 75CM HR17; B0560146

Model Number B0560146

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Device Issue (2379)

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

Event Date 04/29/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: analysis preliminary: ·there are no previous complaints of this code batch.Quantity produced / imported: (b)(4) units of this product and batch number were manufactured and distributed to (b)(4) customers.Background: the database was revised and there are no claims and evidence to date of any reports related to this product and batch number.Batch record / record lot: after reviewing the production batch documentation that was performed it was evident that no deviation, or no alterations occurred during the process.Results for batch release results obtained , were performed giving compliance to the requirements demanded for this type of suture, both the sealing and for the tensile strength in the knot, with parameters of the oem requirements for this suture.Analysis (s) sample (s): the samples received were subjected to a visual examination and evidence that all sutures have the sterilizing solution and have no leakage.Furthermore, 5 units of the received samples were taken, to test resistance voltage at node; in this test it is able to confirm that the lot is in compliance with usp, as demonstrated in the data obtained from this test.Conclusion: in accordance with the results obtained it is determined that this claim is "not justified", since not is detected any irregularity in them analysis made to the samples received.Actions: based on the conclusion derived from investigation, it is not required to take an action on distributed product.

Event Description

Country of complaint: (b)(6).Surgeons state that the suture is easily broken at the time of use in a patient and have abnormal discoloration due to lack of liquid that covers the suture.

Manufacturer Narrative

Samples received: 7 unopened pouch.Analysis and results: there are no previous complaints of this code batch.(b)(4) units were manufactured and distributed of this code batch, there are no units in stock.Tested the knot pull tensile strength of the sample received and the results fulfills the oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements.Samples received were subjected to a visual examination and it was determined that all the sutures had no leaking issues.Five units of the samples received were taken to perform a test of resistance to the voltage at the node, this test confirmed that this lot is in compliance.Final conclusion: complaint is not justified.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions.This complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: CATGUT CHROM 4/0 (2) 75CM HR17
• Type of Device: B0560146
• 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: 5816896
• MDR Text Key: 50310890
• Report Number: 2916714-2016-00566
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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,Followup
• Report Date: 07/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0560146
• Device Catalogue Number: B0560146
• Device Lot Number: 515444
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/07/2016
• Date Manufacturer Received: 08/01/2016
• 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