MAUDE Adverse Event Report: HALYARD - IRVINE CATHETER; UNKNOWN

Model Number UNKNOWN

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: there were no methods performed.The device was not returned, in addition the model and lot number were not available.Therefore, a review of the device history record (dhr) and sterilization certificate could not be performed.Results: as a device was not available for an evaluation, no methods were performed and results cannot be obtained.Conclusion: no conclusion can be drawn as there was no lot information and the model of the device was not reported.Post-operative infection can be due to multiple variables.However we cannot rule out the procedure, pump or catheter as a contributing factor.Without lot and model information the dhr and sterilization cert could not be pulled.Further information regarding the report of infection could not be obtained.If additional information pertinent to this complaint or the sample is received, we will submit a follow-up report.Information from this incident has been included in our product complaint and mdr trend reporting system.Device will not be returned to the mfg.

Event Description

(b)(4).Patient 1 of 2, event 1 of 2: it was reported by our company representative that a scrub tech at a facility reported an incident of infection, the date of event was not provided.The patient had a c-section procedure.The catheter was removed ; however, it was later realized the patient developed an infection.It is unknown if there were any laboratory testing or medical intervention performed due to the report of infection.Further patient consequence was not reported nor the patient's current condition.The patient 's age, weight and gender were also not provided.It is unknown if the infection is related to the surgical procedure, the catheter, or the pump.Sales rep attempted to obtain further information; however, the hospital would not provide anything further.The sample is not available.

• Brand Name: CATHETER
• Type of Device: UNKNOWN
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT S. DE R.L. DE C.V; ave noruega edificio d-1b; fraccionamiento rubio; tijuana, bc 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5146677
• MDR Text Key: 28136587
• Report Number: 2026095-2015-00246
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PUNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Report Date: 09/14/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Model Number: UNKNOWN
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/13/2015
• 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: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other