MAUDE Adverse Event Report: B.BRAUN SURGICAL SA NOVOSYN VIOLET 2/0 (3) 70CM HR26 (M); SUTURES

Model Number C0068042

Device Problem Device Misassembled During Manufacturing /Shipping (2912)

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

Event Date 06/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 open pouch.Analysis and results: there are no previous complaints of the same code-batch.Manufactured (b)(4) units of this code batch.There are (b)(4) units in our stock.Received one open and unused sample of the involved code-batch.Also received one open and unused sample of the code-batch 0068056-117141 (novosyn usp 0 of 70 cm length and hr40s needle), and 1 open pouch of the code-batch 1048090-116474 (safil usp 2/0, 70 cm length and hr26s needle) to compare.Diameter result conducted on the novosyn usp 2/0 sample received is 0.343 mm in average and fulfils the requirements of the european pharmacopoeia (ep) for this size and thread: 0.300 mm < xave < 0.349 mm.The result of the average diameter is in the high range of ep requirements for usp 2/0 size.As stated in the instructions for use of the product: "novosyn® fulfills all the requirements of the european.Pharm.And united states pharm.- current edition - for sterile, synthetic, absorbable sutures (except for an occasional slight oversize in some gauges)".Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfill the oem requirements.On the other hand, the diameter of the other samples received (novosyn usp 0 and safil usp 2/0) corresponds to usp 0 size and usp 2/0 size respectively.In the case of safil usp 2/0, the average value of diameter is in the low range of ep requirements for this size and thread: 0.300 mm < xave < 0.349 mm.Final conclusion: although the result of the sample received fulfill the oem specifications, note of this incident is taken 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.

Event Description

Country of complaint: (b)(6).It was reported that the wrong suture was inside the box.There was a thread size usp 0 instead of 2/0 as specified on the label.

• Brand Name: NOVOSYN VIOLET 2/0 (3) 70CM HR26 (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, 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042
• MDR Report Key: 6708933
• MDR Text Key: 80029492
• Report Number: 3003639970-2017-00350
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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
• Report Date: 07/12/2017

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: 03/20/2022
• Device Model Number: C0068042
• Device Catalogue Number: C0068042
• Device Lot Number: 117121
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/21/2017
• Distributor Facility Aware Date: 07/03/2017
• Initial Date Manufacturer Received: 06/20/2017
• Initial Date FDA Received: 07/12/2017
• 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