MAUDE Adverse Event Report: AAP BIOMATERIALS GMBH SIMPLEX HV WITH GENTAMICIN US 1 PACK; BONOS INJCECT

Catalog Number 01-0309

Device Problem Shelf Life Exceeded (1567)

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

Event Date 04/26/2016

Event Type  malfunction  

Event Description

Three units of expired bonos were used.

• Brand Name: SIMPLEX HV WITH GENTAMICIN US 1 PACK
• Type of Device: BONOS INJCECT
• Manufacturer (Section D): AAP BIOMATERIALS GMBH; lagerstr.11-15; dieburg, 64807 ; GM 64807
• Manufacturer (Section G): AAP BIOMATERIALS GMBH; lagerstr.11-15; dieburg 64807 ; GM 64807
• Manufacturer Contact: lydia heimann ; lagerstr. 11-15; dieburg, 64807 ; GM 64807 ; 071929107
• MDR Report Key: 5669410
• MDR Text Key: 45584045
• Report Number: 9615014-2016-00005
• Device Sequence Number: 1
• Product Code: NDN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K090460
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/20/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 02/29/2016
• Device Catalogue Number: 01-0309
• Device Lot Number: 13BA32030
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/21/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/04/2014
• 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