MAUDE Adverse Event Report: B.BRAUN SURGICAL SA SC UPMD SET; SUTURES

Model Number 75652

Device Problem Detachment of Device or Device Component (2907)

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

Event Date 04/25/2018

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

Country of complaint: (b)(6).It was reported needle detachment and thread breakage.

Manufacturer Narrative

Samples received: 1 closed set.Analysis and results: we have received 1 closed set of this code-batch that contains one unopened pouch of the following references-batches: 0068663 - 117472 (novosyn 0, 90 cm hrn50), 0068381 - 117312 (novosyn 2/0, 70 cm hr40), 0068947 - 117491 (novosyn 1, 70cm hr43), 3046235 - 117411 (novosyn quick 3/0, 70 cm ds24).It is not received in which suture occurred needle detachment and thread breakage.We have analyzed the four references-batches.There are no previous complaints of any of these references-batches.We manufactured and distributed in the market 684 units of the code-batch 0068663 - 117472.There are no units in our stock.We manufactured and distributed in the market 1,764 units of the code-batch 0068381 - 117312.There are no units in our stock.We manufactured and distributed in the market 1,152 units of the code-batch 0068947 - 117491.There are no units in our stock.We manufactured 7,920 units of the code-batch 3046235 - 117411.There are 8 units in our stock that have been requested for analysis.Tightness test to the samples received has been performed and the units are tight.We have tested the needle attachment of the samples received and the results fulfil the requirements of the european pharmacopoeia (ep): code 0068663 and batch 117472: xi= 2.52 kgf (ep requirements: 1.53 kgf in average and 0.46 kgf in minimum).Code 0068381 and batch 117312: xi= 2.44 kgf (ep requirements: 1.12 kgf in average and 0.46 kgf in minimum).Code 0068947 and batch 117491: xi= 3.02 kgf (ep requirements: 1.83 kgf in average and 0.61 kgf in minimum).Code 3046235 and batch 117411: xi= 1.30 kgf (ep requirements: 0.69 kgf in average and 0.35 kgf in minimum).We have also tested the knot pull tensile strength of the novosyn samples received and the results fulfil the requirements of the european pharmacopoeia (ep): code 0068663 and batch 117472: xi= 5.27 kgf (ep requirements: 3.98 kgf in average and 1.89 kgf in minimum).Code 0068381 and batch 117312: xi= 3.68 kgf (ep requirements: 2.73 kgf in average and 1.37 kgf in minimum).Code 0068947 and batch 117491: xi= 6.82 kgf (ep requirements: 5.18 kgf in average and 2.59 kgf in minimum).However, we have tested the knot pull tensile strength of the novosyn quick sample received and the result does not fulfil the requirements of the european pharmacopoeia (ep) for average: code 3046235 and batch 117411: xi= 1.22 kgf (ep requirements: 1.27 kgf in average and 0.76 kgf in minimum).However, with only one value the result of the average can not be performed properly.We have received 8 closed samples from stock and we have tested the knot pull tensile strength and the results fulfil the requirements of the european pharmacopoeia (ep): 1.48 kgf in average and 1.41 kgf in minimum (ep requirements: 1.27 kgf in average and 0.76 kgf in minimum).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfil usp/ep and b.Braun surgical requirements.Remarks: when working with novosyn and novosyn quick suture materials great care should be taken to ensure that, the use of surgical instruments, such as forceps and needle holders, do not cause any crushing or crimping damage to the suture material.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.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: SC UPMD SET
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, 08191 ; SP 08191
• MDR Report Key: 7563053
• MDR Text Key: 110242067
• Report Number: 3003639970-2018-00348
• Device Sequence Number: 1
• Product Code: GAK
• Combination Product (y/n): N
• 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: 06/19/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 75652
• Device Catalogue Number: 75652
• Device Lot Number: P180207005
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/22/2018
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/30/2018
• Date Manufacturer Received: 04/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other