MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP; SYNTHETIC ABSORBABLE BRAIDED S

Model Number C3046651

Device Problems Product Quality Problem (1506); Material Too Rigid or Stiff (1544); Dull, Blunt (2407); Manufacturing, Packaging or Shipping Problem (2975); Material Deformation (2976); Material Integrity Problem (2978)

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510k: reported device not marketed in the u.S., however, similar devices or devices that share components, raw materials, process methods or other technological characteristics are registered within the u.S.K122734.If additional information becomes available, a follow up report will be submitted.

Event Description

It was reported the needle is stiff and rough.The reporter indicated that per the surgeon, the needle is blunt and too traumatic.Tissue tears easily and suture too stiff and rough, making it painful and uncomfortable for patients.The suture is used for episiotomy repair.No patient data available.

Manufacturer Narrative

Investigation: samples received: 2 used sutures and 1 closed pouch.Analysis and results: there are no previous complaints of this code batch of which we manufactured and distributed in the market (b)(4) units.There are no units in stock in b.Braun surgical's warehouse.We have received a closed sample and two used open samples (there are rests of blood in the thread surface).The thread in the open samples received cannot be analyzed as it has been used.Tightness test to the closed sample received has been performed and the unit is tight.We have tested the knot pull tensile strength of the closed sample received and the results fulfill the requirements of the european pharmacopoeia (ep): 3.04 kgf (ep requirements: 2.04 kgf in average and 1.02 kgf in minimum).The thread surface of the closed sample received has been checked and visually, the thread surface is correct and the usual one as can be seen in the enclosed picture.Thread is not damaged.The used needles have been visually checked and the tips are found normal.The needle of the closed sample received has been analyzed for penetration test and the result is 0.578 n in average in the first penetration.This value fulfills the needle specifications of 0.616 n in maximum for the first penetration.Reviewed the needle manufacturing records no deviations have been found and the results in penetration test for the needles before releasing the product were 0.466 n and 0.484 n.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill usp/ep and b.Braun surgical requirements.Final conclusion: although the results of the samples received fulfil the specifications of european pharmacopoeia/ b.Braun surgical specifications, we take note of this incidence in order to assess if new or additional actions are needed.The case is considered not confirmed by evidence of the samples received.Actions on product distributed of this reference/batch: based on the conclusion derived from investigation, it is not required to make actions in distributed product.No corrective/preventive actions needed.

• Brand Name: NOVOSYN QUI UNDY 2/0(3)90CM HRC37S(M)DDP
• Type of Device: SYNTHETIC ABSORBABLE BRAIDED S
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 9214334
• MDR Text Key: 172321534
• Report Number: 3003639970-2019-00722
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• PMA/PMN Number: SEE H10
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 12/09/2019

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: 12/22/2023
• Device Model Number: C3046651
• Device Catalogue Number: C3046651
• Device Lot Number: 118516
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/11/2019
• Initial Date Manufacturer Received: 10/03/2019
• Initial Date FDA Received: 10/21/2019
• Supplement Dates Manufacturer Received: 11/14/2019
• Supplement Dates FDA Received: 12/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1