MAUDE Adverse Event Report: B.BRAUN SURGICAL SA CATGUT PLAIN 5/0 (1.5) 75CM HR17; SUTURES

Model Number B0530131

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 08/04/2015

Event Type  malfunction  

Manufacturer Narrative

Manufacturing site evaluation: stock verification: stock was verified.There is no available units of the product code and lot number.(b)(6) units were manufactured and distributed.No other complaints received regarding this product code and lot number.Reviewed the batch manufacturing record, this product ha a normal process and the results fulfills the oem requirements.A sample is received in open packaging used.Have not received any samples in closed packaging and do not have stocks of the lot, it is not possible to conduct an investigation to determine the cause of the incident.Therefore, in retrospective review of manufacturing and batch release is all that could be performed.Final conclusion: complaint is not justified.Action: no corrective / preventive action is required, since the batch release analysis are satisfactory.Corrective/ preventive actions: not applicable.

Event Description

Country of complaint: (b)(6).Knots do not hold, the knots are loosen.

• Brand Name: CATGUT PLAIN 5/0 (1.5) 75CM HR17
• 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: 5140667
• MDR Text Key: 27952973
• Report Number: 2916714-2015-00856
• 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
• Report Date: 10/07/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/09/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: B0530131
• Device Catalogue Number: B0530131
• Device Lot Number: 514505
• Date Manufacturer Received: 09/07/2015
• 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