MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 2/0 (3) 70CM HR26S (M); SUTURES

Model Number C0068090

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 09/07/2016

Event Type  malfunction  

Manufacturer Narrative

Aesculap inc.(importer) is submitting this report on behalf of (b)(4) (manufacturer).(b)(4).Evaluation on-going.

Event Description

(b)(6).It is reported that the wrong needle was inside the foil.Instead of an hr26s it was a hr30.

Manufacturer Narrative

Samples received: 3 open pouches.Analysis and results: there are no previous complaints of this batch.Manufactured and distributed (b)(4) units of this batch.There are no units in stock.Received three open samples.Checked the open samples received and two of them the first pack contains novosyn suture thread usp 2/0 longer than expected (90cm instead of 70 cm long) and a round bodied needle with smaller wire size (0.68 mm instead of 0.98 mm) and a longer length (37 mm instead of 26 mm).The other open sample received corresponds with the printed information on the first pack (novosyn violet suture of usp 2/0 and 70 cm long and hr26s needle).The incorrect suture found inside two of the three open pouches corresponds to the product manufactured in the previous order as the complained product.Root cause is still under investigation.Nevertheless, the most likely probable cause is assumed to be a human error in the line clearance in the packaging line.Corrective/preventive actions: there is a capa (corrective and preventive action) in order to determine root cause and actions: (b)(4).

• Brand Name: NOVOSYN VIOLET 2/0 (3) 70CM HR26S (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: 6018965
• MDR Text Key: 57056494
• Report Number: 2916714-2016-00855
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/05/2017

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: 03/01/2021
• Device Model Number: C0068090
• Device Catalogue Number: C0068090
• Device Lot Number: 116111V004
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/20/2016
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 10/06/2016
• Device Age: 7 MO
• Initial Date Manufacturer Received: 09/12/2016
• Initial Date FDA Received: 10/11/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/14/2016
• 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