MAUDE Adverse Event Report: B.BRAUN SURGICAL SA CATGUT CHROM 0 (4) 90CM HR37S; SUTURES

Model Number B0565113

Device Problem Failure To Adhere Or Bond (1031)

Patient Problem Wound Dehiscence (1154)

Event Date 03/14/2017

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Preliminary analysis: stock review: lot number was not provided; therefore it is not possible to carry out a traceability and know exactly the lot claimed.Quantity produced / imported: without the lot number, it is not known precisely the number of units manufactured.Distributed quantity: traceability is verified and during the year 2016 and until 2017 this product code has been dispatched 5 different lot numbers to the distributor syd (b)(4), to the supplier of the hospital that reports the incident and the (b)(6) hospital.Background: the database of complaints is reviewed and it is verified that to date a complaint has been received related to this product code; it can not be determined if it corresponds to the batch reported.Batch record: without any closed samples a study cannot be performed to determine if the product fulfills the oem requirements.Analysis of the sample (s): without any closed samples a study can not be performed to see if the affected product does not fulfill the oem requirements.Note is taken of this incident and if any samples are received in the future, the case will be re-opened and analyzed.In case of continuing problems, please send the used sample or its defect 5 units of the same lot, for the corresponding investigation.This information has been entered into our database, and will be included in the trend analysis of this product line.Analysis of the adverse event sanchez-fernandez et al.(2000) described how dehiscence is an adverse event that occurs as a result of the interaction of several preoperative and postoperative factors, including: age greater than 60 years, male gender, hypoalbuminemia, anemia, lung disease, vomiting, cough, diabetes mellitus, jaundice, local infection, steroids, incision type, closure type, and factors related to suturing.Ortiz et al.(2015) add: tumors located below 12 cm measured from the anal margin and advanced t stages.Consequently, with the information provided, it is not possible to reach a conclusion on the root cause of this adverse event.He / she had any of the factors described above besides being male and on the other hand we do not have clarity on the lot of the product.However, this event has been registered in our security database and we have duly reported to invima.Conclusions: this claim is determined as not justified, since without the batch number, no tracking can be performed.If this non-conformity is filed again, please register the corresponding batch number or attach the envelope with the sample.Actions: no corrective or preventive action is required since the batch number was not reported, nor were samples for the assessment of the claim provided.Device not returned.

Event Description

Country of complaint: (b)(6).It was reported that the dehiscence of the sutures which caused open wounds and the patient needed medical/surgical intervention.

Manufacturer Narrative

Samples received: the client did not attach samples for the investigation of the claim.Preliminary analysis: · stock review: lot number was not provided; therefore it is not possible to carry out a traceability and know exactly the lot claimed.· quantity produced / imported: without the lot number, we can not know precisely the number of units manufactured.· distributed quantity: traceability is verified and during the year 2016 and until 2017 this product code has been dispatched 5 different lot numbers to the distributor (b)(4), to the supplier of the hospital that reports the incident and the (b)(6).· background: the database of complaints is reviewed and it is verified that to date a complaint has been received related to this product code; it can not be determined if it corresponds to the batch reported.· batch record: without the batch number, it is not possible to check the manufacturing register; therefore it is not possible to determine if alterations or deviations occurred during the production process.Analysis of the sample (s): as we have not received any samples, nor do we count the batch number of the claimed suture, it is not possible to perform an analysis that leads us to determine the possible cause that generated this incident.In case of continuing with this problem, please send us the used sample or in its defect 5 units of the same lot, for the corresponding investigation.This claim is determined as not evaluable, since without the batch number, no tracking can be performed.If this non-conformity is filed again, please register the corresponding batch number or attach the envelope with the sample.Actions: no corrective or preventive action is required since the batch number was not reported, nor were samples for the assessment of the claim provided.

• Brand Name: CATGUT CHROM 0 (4) 90CM HR37S
• 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: 6516301
• MDR Text Key: 73514619
• Report Number: 3003639970-2017-00209
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 05/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0565113
• Device Catalogue Number: B0565113
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/06/2017
• Date Manufacturer Received: 03/30/2017
• 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