MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. MONOSYN UNDYED 4/0 (1.5) 45CM DSMP13 (M); SYNTHETIC ABSORBABLE SUTURE

Model Number C0023604

Device Problems Battery charger, defective (1054); Detachment Of Device Component (1104)

Patient Problem Not Applicable (3189)

Event Type  malfunction  

Event Description

Country of complint: (b)(6).Needle attachement.

Manufacturer Narrative

Mfg site eval: samples received: 1 open pouch.There are no previous complaints of this code/batch.(b)(4) units of this code-batch were manufactured and distributed.We have received 1 open and used sample with the needle detached from the thread (needle has rests of blood and thread measures 10 cm).Without any closed sample we cannot carry out a complete analysis.Reviewed the batch mfg record, this product had a normal process and the results during the process fulfil oem requirements.Remarks: the complaint is justified for isolated detached needles, but the conclusion is not corresponding according to the results of the in process control when this batch was manufactured.Corrective action: na.

• Brand Name: MONOSYN UNDYED 4/0 (1.5) 45CM DSMP13 (M)
• Type of Device: SYNTHETIC ABSORBABLE SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi (barcelona) 0819 1; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi (barcelona) 0819 1; SP 08191
• Manufacturer Contact: michelle link ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 3880650
• MDR Text Key: 15816413
• Report Number: 2916714-2014-00384
• Device Sequence Number: 1
• Product Code: GAM
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K011375
• 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: 05/22/2014

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 Model Number: C0023604
• Device Catalogue Number: C0023604
• Device Lot Number: 113276
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/24/2014
• 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