MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q EXPANSION KIT: SILVERSOAKER 5 IN (12.5 CM); CATHETER

Model Number PM020-A

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

Patient Problem Unspecified Infection (1930)

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the device was reported as not available for return and analysis.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted, along with obtaining the sterilization certificate.Results: as a device analysis cannot determine the root cause of the post-operative infection, no device testing methods are available.Conclusions: as the device analysis cannot determine the root cause of the post-operative infection, we are unable to determine the cause of the reported event.Post-operative infection can be due to multiple variables.Patient factors, healthcare provider factors, technique factors, medical device/product factors, equipment factors and environmental factors are a few variables to consider.Further information has been requested, however, not yet provided.Information from this incident has been included in our product complaint and mdr trend reporting systems.Trend information is used to identify the need for additional investigations.Should additional information pertinent to this case be received, a follow up report will be submitted.Device not returned for evaluation.

Event Description

Procedure: c-section.Cathplace: asku.Please reference: 2026095-2015-00347/15-01088(a), 2026095-2015-00348/15-01087(a) and 2026095-2015-00349/15-01087(b).Report #2 of #2, patient 1: it was reported by the sales rep that two incidents of infection occurred with (b)(6) within the last 6 weeks.Patient #2: the patient had a c-section.The patient developed a hematoma and had to return to the or for treatment and was prescribed antibiotics for 2 weeks.No further information was provided.The device will not be returning for evaluation.

• Brand Name: ON-Q EXPANSION KIT: SILVERSOAKER 5 IN (12.5 CM)
• Type of Device: CATHETER
• 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-18; fraccionamiento rubio; tijuana, b.c. 22116 ; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5275673
• MDR Text Key: 32987229
• Report Number: 2026095-2015-00347
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 10/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/30/2015
• 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: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention