MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SAFIL VIOLET 3/0(2)8X45CM HR26 TO (M); SUTURES

Model Number M1078171

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 07/19/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: patient information: not available at this moment.Samples received: 9 unopened and 1 open pouches.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed (b)(4) units in the market.There are no units in stock in the warehouse.We have received 9 closed samples and an open and used sample with nine detached needles.There are no threads inside the pack.We have checked the sample received and it can be seen that in the foam, in position five, there is a mark/hole of two needles.It means that two sutures were placed in position one instead of one.Therefore the pack contained nine sutures instead of 8.On the other hand, the nine closed samples received are correct.All contained eight sutures inside.Taking into account that no other customer complaints have been received concerning this issue, we consider that this is an isolated defect.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Final conclusion: taking into account that the results of samples received do not fulfill the oem specifications, we conclude that the complaint is confirmed by evidence of the samples received.

Event Description

It was reported by the healthcare professional to the company sales representative the customer found that 9 sutures in one pouch after using 8 sutures in an operation.The customer counted the number of used sutures for procedure and the wrong quantity was determined.

• Brand Name: SAFIL VIOLET 3/0(2)8X45CM HR26 TO (M)
• 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, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 7795248
• MDR Text Key: 117575852
• Report Number: 3003639970-2018-00494
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: JA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/17/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/14/2023
• Device Model Number: M1078171
• Device Catalogue Number: M1078171
• Device Lot Number: 118201
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2018
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 07/27/2018
• Date Manufacturer Received: 07/19/2018
• 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