MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. CODMAN EXTERNAL DRAINAGE SYSTEM III; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-1730

Device Problem Air Leak (1008)

Patient Problem No Information (3190)

Event Date 05/24/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It has been communicated that the device and/or lot information is not available for evaluation.Without the device and/or lot information it is not possible for codman to conduct a proper investigation.If at some point the device and/or lot information does become available, this complaint will be re-opened, evaluated and a follow up report will be filed.Trends will be monitored for this and similar complaints.At the present time this complaint is considered closed.Device not available.

Event Description

Air is coming out from the drip chamber to the line.The incident has been noted by the sales rep on a patient in the intensive care unit.The hospital has been using the edsiii for many years.Incident not reported to (b)(6) by the hospital.

Manufacturer Narrative

Additional information: to date, we have still not received the product for evaluation or the lot number of the product.While we are unable to confirm the lot number associated with this complaint, a review of sales to this facility has been performed, and all lots of this product number sold to the customer in 2016 were reviewed.No discrepancies related to the reported complaint were noted.If additional information is received in the future, the file will be reopened and a follow-up report will be submitted.At present, we consider this complaint to be closed.

• Brand Name: CODMAN EXTERNAL DRAINAGE SYSTEM III
• 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: 5735329
• MDR Text Key: 47740636
• Report Number: 1226348-2016-10444
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK954021
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign
• Reporter Occupation: Other
• Type of Report: Initial,Followup

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 82-1730
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/28/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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