MAUDE Adverse Event Report: CODMAN & SHURTLEFF, INC. / MEDOS S.A. HAKIM VENTRIC. CATH. W/BACTISEAL, STYLET, AND RA ADAPTOR; SHUNT, CENTRAL NERVOUS SYSTEM & COMPS

Catalog Number 82-3074

Device Problem No Apparent Adverse Event (3189)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/01/2018

Event Type  malfunction  

Manufacturer Narrative

(b)(4).It has been reported that the device was discarded.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the customer via phone, after using a distal catheter kit, it was noticed that the expiration date on the package was (b)(6) 2018.There were no reports of delay or patient harm.

Manufacturer Narrative

Updated udi : (b)(4).The device remains implanted and is therefore not available for evaluation.A review of manufacturing records for this lot found not discrepancies when the device was released to stock.A review of the sales history for this customer showed that the product was received with adequate shelf life.Based on the results of the investigation, no device or process failure was found.Trends will be monitored for this or similar complaints.At present, we consider this complaint to be closed.

• Brand Name: HAKIM VENTRIC. CATH. W/BACTISEAL, STYLET, AND RA ADAPTOR
• Type of Device: SHUNT, CENTRAL NERVOUS SYSTEM & COMPS
• Manufacturer (Section D): CODMAN & SHURTLEFF, INC. / MEDOS S.A.; rue girardet 29; le locle CH 24 00; SZ CH 2400
• MDR Report Key: 7537679
• MDR Text Key: 109108877
• Report Number: 1226348-2018-10365
• Device Sequence Number: 1
• Product Code: JXG
• Combination Product (y/n): N
• PMA/PMN Number: K003322
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,user facility
• Type of Report: Initial,Followup
• Report Date: 05/02/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/23/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Catalogue Number: 82-3074
• Device Lot Number: 143432
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1