MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 4/0 (1.5) 75CM DS19 (M); SUTURES

Model Number C0933244

Device Problem Inadequacy of Device Shape and/or Size (1583)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(6).Manufacturing site evaluation: evaluation on-going.Device not returned.

Event Description

(b)(4).The customer states that the needles are bigger than before.

Manufacturer Narrative

Samples received: there are no samples available.Analysis and results: there are no previous complaints of this code batch.Manufactured and distributed (b)(4) units of this code batch, there are no units in stock.Without any closed sample an analysis cannot be carried out in order to make a decision.Final conclusion: complaint is not justified.Without samples a study can not be performed to see if the affected product does not fulfill the oem requirements.Note is taken of this incidence and if any samples are received in the future, the case will be re-opened and analyzed.Please note that when no samples are received analyzing is very limited.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to take actions in distributed product.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: DAFILON BLUE 4/0 (1.5) 75CM DS19 (M)
• 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: 5567375
• MDR Text Key: 42316250
• Report Number: 2916714-2016-00243
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: GM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/24/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 10/01/2016
• Device Model Number: C0933244
• Device Catalogue Number: C0933244
• Device Lot Number: 615436V004
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 04/01/2016
• Initial Date Manufacturer Received: 03/17/2016
• Initial Date FDA Received: 04/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/24/2016
• 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: N
• Patient Sequence Number: 1