MAUDE Adverse Event Report: B.BRAUN SURGICAL SA CATGUT CHROM 2/0 (3.5) 75CM HR26; OTHER SUTURE

Model Number B0560430

Device Problems Fluid/Blood Leak (1250); Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 10/08/2019

Event Type  malfunction  

Manufacturer Narrative

Investigation on-going.Additional information / investigation results will be provided in a supplemental report.

Event Description

It was reported that there was an issue with catgut.The distributor noted that the solution within the packet had leaked.There was no patient involvement.

Manufacturer Narrative

Samples received: 1 unopened pouch.Analysis and results: there are no previous complaints of this code batch.There are (b)(4) units blocked in b.Braun surgical's warehouse.We have received a closed unit with leakage in the pack.The sample received is empty of liquid.Leakage is caused by a defect in the sealing step which is not detected in the process, only after a time when the solution makes contact with the affected part of the aluminum and caused deterioration of it.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Please note that the product must be stored under 25ºc as indicated in the product label.Final conclusion: taking into account that the results of samples received do not fulfil the b.Braun surgical specifications, we conclude that the complaint is confirmed by evidence of the samples received.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.

• Brand Name: CATGUT CHROM 2/0 (3.5) 75CM HR26
• Type of Device: OTHER SUTURE
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9287754
• MDR Text Key: 172026814
• Report Number: 3003639970-2019-00776
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• PMA/PMN Number: K991223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/06/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0560430
• Device Catalogue Number: B0560430
• Device Lot Number: 618174
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 12/02/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1