MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. NOVOSYN VIOLET 0 (3.5) 70CM FR26 (M) ; SUTURES

Model Number C0068416

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Type  malfunction  

Manufacturer Narrative

Mfg site eval: samples received: 1 open pouch.Analysis and results: there are no previous complaints of this code batch.A (b)(4) units of this code batch, there are no units in stock.Received one open and empty sample, there are no needle nor thread inside.The open sample received were checked and there are no marks of needle observed, therefore there was not suture inside the pack.This mistake was probably produced during the automatic packaging step in the mfg line.Reviewed the batch mfg record, this product had a normal process and the results during the process fulfilled oem requirements.Taking into account that no other customer complaints have been received of this code batch, it is considered that this is an isolated unit.Final conclusion: complaint is justified.Corrective/preventive actions: this complaint will be included in the analysis of trending, and corrective action will be open if applies.Corrective/preventive actions: this complaint will be included in the analysis of trending, and corrective action will be open if applies.

Event Description

Country of complaint: (b)(6).Customer complained that the package was empty, the thread was missing.

• Brand Name: NOVOSYN VIOLET 0 (3.5) 70CM FR26 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; 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 dr. ; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4992746
• MDR Text Key: 23129753
• Report Number: 2916714-2015-00689
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K122734
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/07/2015

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?: Yes
• Device Operator: Health Professional
• Device Model Number: C0068416
• Device Catalogue Number: C0068416
• Device Lot Number: 115091
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other