MAUDE Adverse Event Report: INTEGRA NEURO SCIENCES CA/USA INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K

Catalog Number 1104BT

Device Problems Device Packaging Compromised (2916); Device Contamination with Chemical or Other Material (2944)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

This is the first of two reports (same product id, same problem, same lot number, same reporter, different serial numbers).During inspection of products by the distributor, foreign material was found inside the sterilized package.There was no patient involvement.

Manufacturer Narrative

To date, the device involved in the reported incident has not been received for evaluation.An investigation has been initiated based upon the reported information.

Manufacturer Narrative

Integra has completed their internal investigation on (b)(4) 2015.The investigation included: methods: evaluation of actual device, review of device history records, review of complaints history.Results: visual inspection was performed in accordance with procedure.A review of batch history record indicates that lot met requirements before released to finished goods.Lot info.Mfg 18 mar 2015 and exp 30 sep 2017.Complaint history, model 110-4xxx, from jul-2014 through jun-2015 reviewed; no other complaints issued with similar failure.Conclusion: the reported customer complaint that there was ¿foreign material inside the sterilized package¿ was verified.The package was inspected by five different operators under the site workmanship standards and resulted in two out of the five operators identifying foreign matter within the packaging.It was confirmed that the particulate size did not meet the ¿acceptable¿ particulate size limit called out in integra procedure.The root cause of the customer complaint is that foreign matter was present within the packaging.Engineering performed further investigation on the particulate by inspecting the particulate, tray foam, tyvek, and tray under 50x magnification.It was concluded that the most probable origin of the particulate was particulate residing in product tray or the tyvek tray lid.

• Brand Name: INTRACRANIAL PRESSURE/TEMPERATURE MONITORING K
• Type of Device: NA
• Manufacturer (Section D): INTEGRA NEURO SCIENCES CA/USA; san diego CA 92121
• Manufacturer (Section G): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: rowena bunuan ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 4918147
• MDR Text Key: 21552745
• Report Number: 2023988-2015-00022
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K102875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor,distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1104BT
• Device Lot Number: 3050RY326730
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/22/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/22/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/18/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1