MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3072

Device Problem Packaging Problem (3007)

Patient Problem No Information (3190)

Event Date 03/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Upon completion of the investigation a follow up report will be filed.

Event Description

During qa incoming goods inspection, the operator found that temperature monitor indicated temperature was out of range on product label.The temperature exceeded high limit (27c) on (b)(6) 2016.The temperature-indicating label didn't turn red.Now the goods are pending at warehouse.Please be advised if the goods need to be returned for investigation.

Manufacturer Narrative

(b)(4).It was initially reported that the device would be returned for evaluation.However, multiple attempts to obtain the sample were unsuccessful.This report has been updated to reflect the corrected information complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.Manufacturing records for the affected lot were reviewed and the device was found to have met specification when released to stock.A review of complaint records found no similar complaints for the reported lots.The cause(s) of the difficulty reported by the customer could not be determined.Complaint will be closed at this time as 'no complaint sample returned to codman for evaluation'.If the complaint sample becomes available, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: HAKIM VENTRICUALR & PERITONEAL CATHETERS WITH BACTISEAL
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; ch-2400 le locle ; SZ
• Manufacturer Contact: james kenney ; 325 paramount drive; raynham, MA 02767 ; 5088282726
• MDR Report Key: 5580659
• MDR Text Key: 42771539
• Report Number: 1226348-2016-10304
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK003322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2016
• Device Catalogue Number: 82-3072
• Device Lot Number: CVCBKM
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/25/2016
• Initial Date FDA Received: 04/15/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 05/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/16/2016
• 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
• Treatment: 82-3074