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

Catalog Number 82-3072

Device Problem Residue After Decontamination (2325)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Multiple attempts to obtain the sample have not been successful.A lot number has been provided.Upon completion of the investigation, a follow-up report will be submitted.

Event Description

As reported by the rep, while being primed prior to implantation, the peritoneal portion of a hakim catheter with bactiseal exuded an oily red bead-shaped substance and was not used.There were no reports of delay or patient harm.

Manufacturer Narrative

Complaint sample was not returned to codman; therefore, an evaluation of the device could not be performed.A review of manufacturing records found no discrepancies when the device was released to stock.The cause(s) of the difficulty reported by the customer could not be determined.If additional relevant information becomes available in the future, this complaint will be reopened, and the respective evaluation performed.Trends will be monitored for this and similar issues.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.; 325 paramount drive; raynham MA 02767
• MDR Report Key: 8141950
• MDR Text Key: 129611337
• Report Number: 1226348-2018-10847
• 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: user facility
• Type of Report: Initial,Followup
• Report Date: 11/12/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/07/2018
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2019
• Device Catalogue Number: 82-3072
• Device Lot Number: 205953
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/17/2018
• Patient Sequence Number: 1