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

Catalog Number 1104BT

Device Problems Break (1069); Out-Of-Box Failure (2311)

Patient Problems No Patient Involvement (2645); No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

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.

Event Description

The outer package was broken but the package inside was unbroken.The package was not used.The problem was found by the distributor.

Manufacturer Narrative

Integra has completed their internal investigation on 10/23/2015.The investigation included: methods: evaluation of actual device.Review of device history records.Review of complaints history.Results: a review of batch history record indicates that lot met the requirements before released to finished goods.Lot info.: lot no.305000301322, mfg date: 25 aug 2014 and exp.Date: 31 aug 2017 complaint history, model 110-4xxx, from aug-2012 through aug-2015 reviewed; there was no other complaint that issued with complaint code.Conclusion: the reported customer complaint that the ¿the outer package in broken, but the package inside is unbroken¿ was verified.The returned product was examined and the product carton appeared to be damaged.It is important to note that the sterile barrier was not damaged or affected by the product carton damage.The root cause of this issue can be attributed to shipping or storage conditions.

• 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: 4996060
• MDR Text Key: 24256936
• Report Number: 2023988-2015-00026
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: unknown
• Reporter Occupation: Other
• Type of Report: Followup
• Report Date: 07/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/06/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1104BT
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2015
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/23/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/25/2014
• 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