MAUDE Adverse Event Report: B.BRAUN SURGICAL SA PREMILENE 2/0 (3) 75CM HR30 (M); SUTURES

Model Number C2090047

Device Problems Loose or Intermittent Connection (1371); Device Packaging Compromised (2916)

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

Event Date 01/06/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: evaluation on-going.

Event Description

Country of complaint: (b)(6).Needle was already loose from the thread, still inside the packaging.

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: 1 open racepack.Analysis and results: there is one previous complaint of the same reference-batch.(b)(4).Reviewed the batch manufacturing record, this product had a normal process and the results during the process fulfills the oem requirements.Final conclusion: complaint is justified.Taking into account that there is one previous complaint that the results did not fulfill the oem requirements.Actions on product: replace this code/batch to the customer or issue a refund.Corrective/preventive actions: this complaint is recorded for trending analysis to assess if actions are needed in the future.

• Brand Name: PREMILENE 2/0 (3) 75CM HR30 (M)
• Type of Device: SUTURES
• Manufacturer (Section D): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B.BRAUN SURGICAL SA; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe drive; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 5501620
• MDR Text Key: 40635118
• Report Number: 2916714-2016-00204
• Device Sequence Number: 1
• Product Code: GAW
• Combination Product (y/n): N
• Reporter Country Code: PO
• PMA/PMN Number: K980703
• 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,Followup
• Report Date: 04/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: C2090047
• Device Catalogue Number: C2090047
• Device Lot Number: 114223
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Distributor Facility Aware Date: 03/14/2016
• Date Manufacturer Received: 02/19/2016
• 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