MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 0 (3.5) 70CM HRN35 (M); SUTURES

Model Number C0068518

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 the wrong needle was attached.Instead of a blunt point it was a triangular point.

Manufacturer Narrative

Samples received: 237 unopened pouches and 6 opened.Analysis and results: there are no previous complaints of this batch.We manufactured (b)(4) units of this batch.There are (b)(4) units in stock blocked.We have received 243 samples for analysis (237 closed samples and 6 open and unused samples).We have checked these 243 samples and we have found two particular cases: particular case 1: 235 of them contain inside the first pack a novosyn violet suture of usp 1 size and 70 cm length with hrt37 needle (equivalent product code c0068391).Particular case 2: 8 of them contain inside the first pack a novosyn violet suture of usp 0 size and 70 cm length with hrc40 needle (equivalent product code c0068909).After internal investigation, we have found that for the particular case 1, the incorrect suture found inside (b)(4) units corresponds to the code-batch c0068391-115225 (novosyn violet 1 (4) 70cm hrt37).The most likely cause is assumed to be a human error in the packaging line.The operator by mistake placed the container that contained the sutures of the code-batch (c0068391-115225) instead of the sutures of the involved code-batch (c0068518-117216) in the packaging line.Concerning the particular case 2, the incorrect suture found inside eight pouches received from the customer corresponds to the code-batch c0068909-117216 (novosyn violet 0 (3.5) 70cm hrc40), product manufactured in the subsequent order of the complained product.The most probable cause is assumed to be a human error for failing to perform correctly the the line clearance in the packaging line.Both products were conditioned the same day, one after the other one and some units of the code-batch c0068909-117216 were packed as the complained code-batch (c0068518-117216).Remarks: an internal communication has done to inform the personnel involved about the incidence.Final conclusion: we conclude that the complaint is justified.Actions on distributed product of this reference/batch: replace this code/batch to the end customer or refund.Corrective/preventive actions: there is an improvement project to avoid this kind of defect happen again: (b)(4).

• Brand Name: NOVOSYN VIOLET 0 (3.5) 70CM HRN35 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 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: 6747718
• MDR Text Key: 81191298
• Report Number: 3003639970-2017-00383
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: SP
• 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: 10/17/2017

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: 05/27/2022
• Device Model Number: C0068518
• Device Catalogue Number: C0068518
• Device Lot Number: 117216
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/14/2014
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 07/13/2017
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/27/2017
• Supplement Dates Manufacturer Received: 07/06/2017
• Supplement Dates FDA Received: 10/18/2017
• 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