MAUDE Adverse Event Report: B.BRAUN SURGICAL SA DAFILON BLUE 5/0 (1) 45CM DS19; SUTURES

Model Number C0932191

Device Problems Misassembled (1398); Incomplete or Missing Packaging (2312)

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

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).No needle or suture in a pack.Suture missing inside pack.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 30 unopened and 4 open pouches.Analysis and results: there are no previous complaints of the same reference-batch.(b)(4) units were manufactured and distributed of this code batch, there are no units in stock.Received 30 closed samples and 4 open samples, two of them have sutures inside and the other two packs are empty.After checking both empty packs under microscope it was observed that there are marks/signs of a needle or thread in the support cardboard.All closed samples received have been opened and all packs have sutures inside.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements.Final conclusion: complaint is not justified.Although the samples received fulfill the oem requirements, note has been taken of this incidence in order to assess if new or additional actions are needed.Actions on product: based on the conclusion derived from investigation, it is required to take an action on distributed product.A credit note for one box of product as a quality courtesy.Corrective/preventive actions: according to the internal procedures, there is no need to establish corrective or preventive actions.This complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: DAFILON BLUE 5/0 (1) 45CM DS19
• 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: 5197759
• MDR Text Key: 30261335
• Report Number: 2916714-2015-00966
• Device Sequence Number: 1
• Product Code: GAR
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: K990090
• 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: 01/22/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C0932191
• Device Catalogue Number: C0932191
• Device Lot Number: 615091
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/06/2015
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Other