MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SURGICAL LOOP SIL.WHITE 1.2MM 2X45 DRN25; SUTURES

Model Number B1095552

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: none.Analysis and results: there are no previous complaints of this code-batch.The (b)(4) units were manufactured and distributed in the market.There are no units in stock.Without any closed sample an analysis cannot be carried in order to make a decision.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.Final conclusion: complaint is not justified.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.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.

Event Description

Country of complaint: (b)(6).It was reported by the surgeon that the needle was not blunt enough.It was too sharp and traumatic.

• Brand Name: SURGICAL LOOP SIL.WHITE 1.2MM 2X45 DRN25
• 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: 6422010
• MDR Text Key: 70752966
• Report Number: 3003639970-2017-00156
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: EXEMPT
• 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
• Report Date: 03/21/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1095552
• Device Catalogue Number: B1095552
• Device Lot Number: 614441
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 03/15/2017
• Date Manufacturer Received: 02/20/2017
• Was Device Evaluated by Manufacturer?: No
• 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