MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 6/0(0.7)45CM 2XVLM8 (M; SUTURES

Model Number G0068734

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that in two boxes of the same product, there were two pieces found that the content was different from the description on the packaging.Instead of violet thread combined with 2xvlm8 needle, the undyed thread with single short cutting needle was found.

Manufacturer Narrative

Samples received: 4 open pouches.Analysis and results: there are no previous complaints of this batch.Manufactured and distributed (b)(4) of this batch.There are (b)(4) units in stock that have been blocked.Received four open and unused samples.Checked these samples and three of them the first pack contains a novosyn undyed suture with a bigger usp size (5/0 instead of 6/0), same thread length (45cm) and one dsmp16 needle instead of two vlm8 needles.The other open sample received contains a suture that corresponds to the printed information in the first pack (novosyn violet suture of usp 6/0, 45 cm long and two vlm8 needles).Checked the 40 units blocked from stock and the suture of all of them corresponds to the printed information in the first pack (novosyn violet suture of usp 6/0, 45 cm long and two vlm8 needles).The incorrect suture found inside three of the four open pouches received from the customer corresponds to the product manufactured in the subsequent order of the complained product.The most likely probable cause is assumed to be a human error in the line clearance in the packaging line.Remarks: we will inform the personnel involved about this incidence and a training will be done to reinforce the importance of applying the procedure of the line clearance correctly.Corrective/preventive actions: this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: NOVOSYN VIOLET 6/0(0.7)45CM 2XVLM8 (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: 6407537
• MDR Text Key: 70062001
• Report Number: 3003639970-2017-00115
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: PL
• 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
• Type of Report: Initial,Followup
• Report Date: 04/18/2017

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 Expiration Date: 10/30/2021
• Device Model Number: G0068734
• Device Catalogue Number: G0068734
• Device Lot Number: 116437
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/28/2017
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 02/23/2017
• Initial Date Manufacturer Received: 02/15/2017
• Initial Date FDA Received: 03/15/2017
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/01/2017
• 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