MAUDE Adverse Event Report: B.BRAUN SURGICAL SA CATGUT PLAIN 2/0 (3.5) 150CM; SUTURES

Model Number B0032077

Device Problem Packaging Problem (3007)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Manufacturing site evaluation: samples received: none, but pictures attached.Analysis and results: there are no previous complaints of this code batch.(b)(4) units of this product were manufactured and distributed in the market, there are no units in stock.Received a picture of an unopened box.The box label corresponds to catgut plain 2/0 150cm, the same as the product inside the box.However, the box corresponds to softcat.This error took place in the manufacturing line in the packaging step, the operator packed the product in the wrong box.Final conclusion: the complaint is justified.Taking into account that the picture received shows that the product does not fulfill the oem specifications.Corrective/preventive actions: according to our internal procedures, there is no need to establish corrective or preventive actions.Nevertheless, this complaint is recorded for trending analysis to assess if actions are needed in the future.Received pictures.

Event Description

Country of complaint: (b)(6).It is reported that the box had the wrong label on it.The product is labeled as b0032077 (catgut plain 2/0 (3.5) 150cm), but pre-printed box is for softcat.

• Brand Name: CATGUT PLAIN 2/0 (3.5) 150CM
• 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: 6071229
• MDR Text Key: 58931623
• Report Number: 2916714-2016-00911
• Device Sequence Number: 1
• Product Code: GAL
• Combination Product (y/n): N
• PMA/PMN Number: K991223
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial
• Report Date: 11/01/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/05/2021
• Device Model Number: B0032077
• Device Catalogue Number: B0032077
• Device Lot Number: 616184
• Was Device Available for Evaluation?: No
• Distributor Facility Aware Date: 10/21/2016
• Device Age: 6 MO
• Date Manufacturer Received: 10/04/2016
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 05/05/2016
• 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