MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 1 (4) 75CM HR37S (M) POW; SUTURES

Model Number C0095554

Device Problem Loose or Intermittent Connection (1371)

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

Event Date 04/06/2017

Event Type  malfunction  

Manufacturer Narrative

Reported device not marketed in the u.S., however, similar devices or devices that share components, (b)(4) materials, process methods or any other technological characteristics with a medical device that is registered within the u.S.(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).It was reported that when the suture package was opened the needle was loose from the thread.

• Brand Name: PREMILENE 1 (4) 75CM HR37S (M) POW
• 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: 6747741
• MDR Text Key: 81191273
• Report Number: 3003639970-2017-00386
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: CO
• 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: 07/27/2017

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 Model Number: C0095554
• Device Catalogue Number: C0095554
• Device Lot Number: 515204
• Was Device Available for Evaluation?: Yes
• Distributor Facility Aware Date: 07/13/2017
• Initial Date Manufacturer Received: 07/06/2017
• Initial Date FDA Received: 07/27/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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