MAUDE Adverse Event Report: HALYARD - IRVINE SURGPN,ON-Q_QUIKBLO,STIML,-,20GX100,5; CATHETER

Model Number QB10016SGC

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

Patient Problem Unspecified Infection (1930)

Event Date 11/01/2015

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.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, environmental factors are a few variables to consider.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.Device not to be returned for evaluation.

Event Description

Fill volume: asku.Flow rate: asku.Procedure: interscalene nerve block.Cathplace: arm.Report #2 of 2: reference (b)(4) was opened to address the pump, mdr#2026095-2015-00332.Report #1 of 2: it was reported by an anesthesiologist that on (b)(6) 2015 after an interscalene nerve block procedure, the patient called the anesthesiologist and stated she noticed some redness around the catheter insertion site.The anesthesiologist prescribed the patient keflex.On (b)(6) 2015, the anesthesiologist called the patient and it was reported that pus was now coming out of the insertion site.The catheter was removed 24 hours prior during pod 3.The patient had a manipulation of her shoulder for a right frozen shoulder under anesthesia.The anesthesiologist decided to wait another 24 hours with the patient taking keflex, to determine if any further prescription will be prescribed.No culture has been performed at this time.Device is not available for return and the lot number is unavailable.The catheter was used on the patient along with a pump.0.2% ropivacaine was used in the pump.It was reported that no pre-existing medical conditions were present.No sterile barrier was compromised during the procedure.

• Brand Name: SURGPN,ON-Q_QUIKBLO,STIML,-,20GX100,5
• Type of Device: CATHETER
• Manufacturer (Section D): HALYARD - IRVINE; 43 discovery; suite 100; irvine CA 92618
• Manufacturer (Section G): AVENT, INC.; 6620 memorial place; suite 100; tucson AZ 85756
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5262353
• MDR Text Key: 32587213
• Report Number: 2026095-2015-00330
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK143164
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/02/2015

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?: No
• Device Operator: Physician
• Device Model Number: QB10016SGC
• Device Catalogue Number: 104305700
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 11/02/2015
• Initial Date FDA Received: 12/02/2015
• 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
• Patient Age: 58 YR