MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. SAFIL QUI+ UNDY 4/0 (1,5) 70CM HR22 (M); SYNTHETIC ABSORBABLE SUTURE

Model Number C1046029

Device Problems Battery charger, defective (1054); Break (1069)

Patient Problem Not Applicable (3189)

Event Date 04/21/2014

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Thread breaks easily.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Manufacturing site evaluation: samples received: 24 unopened pouches.There are no previous complaints of this code/batch.All packs received are tight.Tested the knot pull tensile strength of the samples received and the results fulfil the requirements of the oem.Knot pull tensile strength results before releasing the product fulfilled oem requirements.Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfils oem requirements.Final conclusion: the complaint is not corresponding (not justified).Corrective/preventive actions: not applicable.

• Brand Name: SAFIL QUI+ UNDY 4/0 (1,5) 70CM HR22 (M)
• Type of Device: SYNTHETIC ABSORBABLE SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3880717
• MDR Text Key: 4510403
• Report Number: 2916714-2014-00412
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: DA
• PMA/PMN Number: K031286
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2019
• Device Model Number: C1046029
• Device Catalogue Number: C1046029
• Device Lot Number: 114055
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/21/2014
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 01/01/2014
• 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