MAUDE Adverse Event Report: B.BRAUN SURGICAL SA MEDIUM CHROM CATGUT 1 (5) 75M BAYER EE; SUTURES

Model Number 41167236

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Blood Loss (2597)

Event Date 12/19/2017

Event Type  Death  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

Country of complaint: (b)(6).Acute bleed from vulva.X-lap huge granuloma at the cervical stump & adhesions to the bladder.Surgical correction & the dog so far is doing well.

Manufacturer Narrative

Samples received: (b)(4) open cassette.Analysis and results: there are no previous complaints of this code batch.We have received the same day two cases of the same code-batch and from the same end customer.We manufactured and distributed in the market (b)(4) units of this code batch.There are no units in our stock.We have received one open and used cassette.Unfortunately, the sterility of the thread cannot be analyzed as the cassette has been used.Without any closed and unused sample we cannot carry out an analysis in order to take a decision.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.This batch had also a normal sterilization process and the sterilization control was correct.Reviewed the complaint history, there are no other complaints regarding this issue in any of the other products manufactured with the same thread raw material batches, as the used in this product.On the other hand, we have not received any other complaint regarding this issue in any of the other products that were in the same sterilization cycle.Remarks: there is no time frame in which catgut can be used once opened as long as the product is used within the shelf life.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.

Manufacturer Narrative

Samples received: 1 open cassette.Analysis and results: there are no previous complaints of this code batch.We have received the same day two cases of the same code-batch and from the same end customer.We manufactured and distributed in the market (b)(4) units of this code batch.There are no units in our stock.We have received one open and used cassette.Although a proper analysis cannot usually be carried out when the cassette received is open and used, we have finally been decided to perform the sterility test in the thread of the samples received.The samples incubated for 14 days remained without microbial growth.Therefore, the samples comply with the sterility test.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.This batch had also a normal sterilization process and the sterilization control was correct.Reviewed the complaint history, there are no other complaints regarding this issue in any of the other products manufactured with the same thread raw material batches, as the used in this product.On the other hand, we have not received any other complaint regarding this issue in any of the other products that were in the same sterilization cycle.Remarks: there is no time frame in which catgut can be used once opened as long as the product is used within the shelf life.Final conclusion: although the results of the samples received fulfil the b.Braun surgical specifications, we take note of this incidence 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.

• Brand Name: MEDIUM CHROM CATGUT 1 (5) 75M BAYER EE
• 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, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 7207778
• MDR Text Key: 97844527
• Report Number: 3003639970-2018-00051
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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,Followup
• Report Date: 03/13/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/19/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2021
• Device Model Number: 41167236
• Device Catalogue Number: 41167236
• Device Lot Number: 616134
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 01/12/2018
• Date Manufacturer Received: 01/03/2018
• 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