MAUDE Adverse Event Report: B.BRAUN SURGICAL S.A. PREMILENE/MONOSYN SET; SUTURES

Model Number B0990045

Device Problem Misassembled (1398)

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

Event Type  malfunction  

Manufacturer Narrative

Pma/510 (k) # k980703 / k011375.Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).The customer stated that the set did not contain four different articles as per product specification.Also, the customer reported that 12 samples of one article were found inside.Additional information provided on july 22, 2015 were the following: premilene 3/0 ds 24- 12 samples inside.Premilene 2/0 ds 30 is missing.

• Brand Name: PREMILENE/MONOSYN SET
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL S.A. ; rubi (barcelona) 08191 ; ES 08191
• Manufacturer (Section G): B. BRAUN SURGICAL SA ; 121 carretera de terrassa; rubi (barcelona) 08191 ; ES 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4992701
• MDR Text Key: 23248407
• Report Number: 2916714-2015-00674
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: NARRATIVE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Report Date: 08/04/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/07/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 01/01/2020
• Device Model Number: B0990045
• Device Catalogue Number: B0990045
• Device Lot Number: M150527002
• Date Manufacturer Received: 07/15/2015
• 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