MAUDE Adverse Event Report: B. BRAUN SURGICAL S.A. STEELEX STE SET 5 (7) 4X45CM HRC48 (M) LP; SUTURE

Model Number G0617135

Device Problem Packaging Problem (3007)

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

Event Type  malfunction  

Event Description

Country of complaint: (b)(6).Plastic seal is broken/opened.

Manufacturer Narrative

U.S.Reporting agent notified on: (b)(4) 2015.Mfg site investigation: eval on-going.

Manufacturer Narrative

Manufacturing site evaluation: samples received: 23 long packs.(all open).There are no previous complaints of this code batch.A total of (b)(4) units were manufactured and distributed into the market, there are no units in stock.All 23 units received have the sealing not properly performed in one of the packaging.All units have marks of being sealed but the closed pack are not sealed.The defective units were not detected by the personnel involved in the manufacturing line.Final conclusion: complaint is justified.Corrective/preventive actions: we have opened a corrective action in order to avoid this kind of incident in the future.

• Brand Name: STEELEX STE SET 5 (7) 4X45CM HRC48 (M) LP
• Type of Device: SUTURE
• Manufacturer (Section D): B. BRAUN SURGICAL S.A.; rubi, barcelona 08191 ; SP 08191
• Manufacturer (Section G): B. BRAUN SURGICAL S.A.; 121 carretera de terrassa; rubi, barcelona 08191 ; SP 08191
• Manufacturer Contact: nicole broyles ; 615 lambert pointe dr; hazelwood, MO 63042 ; 3145515988
• MDR Report Key: 4875660
• MDR Text Key: 18875358
• Report Number: 2916714-2015-00542
• Device Sequence Number: 1
• Product Code: GAQ
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: K023411
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative,company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/23/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/24/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/01/2019
• Device Model Number: G0617135
• Device Catalogue Number: G0617135
• Device Lot Number: 614314
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2015
• 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