MAUDE Adverse Event Report: INTEGRA NEUROSCIENCES CA/USA OLM INTRACRANIAL PRESSURE MONITORING KIT; N/A

Catalog Number 1104B

Device Problems Delivered as Unsterile Product (1421); Device Packaging Compromised (2916)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Event Description

A report was received that the customer received several camino probe packages in a parcel and one of the device boxes was found to be placed in the opposite way than the others.When he checked more deeply he discovered that the packaging inside the box was opened.Images of the incident were provided.There was no patient contact, injury or delay in procedure since the issue was discovered by the distributor.The open device will be returned.

Manufacturer Narrative

Integra has completed their internal investigation on 11/28/2016.The investigation included: methods: -evaluation of actual device.-review of complaint history.Results: evaluation of device: this item was picked from location 3h14a1 (main warehouse), previous move was rec (=receiving area).Received on inbound 1096986.On inbound 1097310 there were 3 items of this lot booked as damaged.Location me31c2 ( qa area), previous move was receiving area.There is no indication in any of the dsv records on incoming or outgoing shipments that could explain the damage.No trend has been identified - this is a one time event.Conclusion: it is not possible to determine the root cause.It currently considered as one time event.

• Brand Name: OLM INTRACRANIAL PRESSURE MONITORING KIT
• Type of Device: N/A
• Manufacturer (Section D): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer (Section G): INTEGRA NEUROSCIENCES CA/USA; 5955 pacific center boulevard; san diego CA 92121
• Manufacturer Contact: bina patel ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 5688575
• MDR Text Key: 47190955
• Report Number: 2023988-2016-00013
• Device Sequence Number: 1
• Product Code: GWM
• Combination Product (y/n): N
• PMA/PMN Number: K102875
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/10/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/31/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 1104B
• Device Lot Number: 111EOX117051
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/28/2016
• 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: Unknown
• Patient Sequence Number: 1