MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. SURGICAL LOOP SIL. WHITE 1.2 MM 2X45

Model Number B1095552

Device Problem Product Quality Problem (1506)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Needle is pointed instead of blunt.

Manufacturer Narrative

Us reporting agent notified on (b)(4) 2014.Mfg site eval.Samples received: 41 unopened and 3 opened units.There are no previous complaints of this code/batch.There are no units in stock.Needle puncture strength test is determined using a porvair membrane of 0.4 mm to be penetrated by the needles and to determine the puncture strength of the needles.Each needle is tested with 10 punctures.The average result is 446 g.This results is in the same range of the standard for these needles.Reviewed the batch mfg record.This product had a normal process and the results during the process fulfill oem requirements.Final conclusion: the complaint is not corresponding (not justified).Corrective/preventive action not applicable.

• Brand Name: SURGICAL LOOP SIL. WHITE 1.2 MM 2X45
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi, barcelona, es
• Manufacturer (Section G): B. BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona, es
• Manufacturer Contact: michelle link ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515938
• MDR Report Key: 4030362
• MDR Text Key: 18030397
• Report Number: 2916714-2014-00508
• Device Sequence Number: 1
• Product Code: GAD
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 07/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/18/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B1095552
• Device Catalogue Number: B1095552
• Device Lot Number: 613495
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 04/23/2014
• 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