MAUDE Adverse Event Report: HALYARD ON-Q PAINBUSTER AND SILVER SOAKER CATHETER; ELESTOMERIC PUMP

Model Number UNK- ANP

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/23/2014

Event Type  malfunction  

Event Description

Fill volume, flow rate, procedure, cathplace: unk-anp (asked not provided).A foreign distributor reported over infusion.The incident was described as "overinfusion, no drops possible." it was reported that there was no adverse event, pt injury or medical intervention required as a result of the incident.Pt's current condition was not provided.

Manufacturer Narrative

A visual inspection was performed on the device received and found only a portion of a device was returned.In addition the portion received was a unused catheter in a sealed pouch.Add'l info has been requested regarding the device received and incident reported.Method: the actual device involved in the reported incident was not returned for analysis, at this time clarification has been requested.Results: at this time the investigation is still in progress.Results will be provided once completed.Conclusions: clarification has been requested, but not yet received, therefore, a f/u report will be submitted upon completion of our investigation.Info from this incident has been included in our product complaint and mdr trend reporting systems.Trend info is used to identify the need for add'l investigation.

• Brand Name: ON-Q PAINBUSTER AND SILVER SOAKER CATHETER
• Type of Device: ELESTOMERIC PUMP
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4360662
• MDR Text Key: 21244674
• Report Number: 2026095-2014-00286
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Distributor
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 11/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: UNK- ANP
• Device Catalogue Number: UNK - ANP
• Device Lot Number: UNK - ANP
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 12/10/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 11/26/2014
• Was Device Evaluated by Manufacturer?: No
• 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: DRUG: UNK-ANP