MAUDE Adverse Event Report: HALYARD T17X8, TUNNELER, DISPOSABLE, 17GA, 8IN; ON-Q INTRODUCERS

Model Number 101373901

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

Patient Problems Erythema (1840); Unspecified Infection (1930)

Event Date 10/13/2014

Event Type  Injury  

Event Description

Procedure: peripheral nerve stimulator implants.Please reference: 2026095-2014-00259/14-01007 (b), 2026095-2014-00260/14-01007 (c), 2026095-2014-00261/14-01007 (d).Report 1 of 4: a surgery center reported that 4 of their pts had an infection after they underwent peripheral nerve stimulator implants surgeries.Spinal cord stimulator, peripheral nerve stimulator leads, and generator were implanted for these pts.The on-q tunnelers were placed subcutaneously during surgery and used to thread the wires of the stimulators.A potential lot number was received by the reporter, but unable to confirm if this was the suspect lot.Pt 2: the pt was diagnosed with an infection on (b)(6) 2014 via the assessment of the surgical site, which was hot to touch.No culture was obtained.The pt was treated with cleocin and doxycycline.The products were removed on (b)(6) 2014.The pt responded to the treatment well with infection resolving.It was reported that the tunnelers were discarded after use.

Manufacturer Narrative

Method: the device was reported as not available for return and analysis.The reporter was unable to provide a suspect lot number; however, three potential lot numbers were identified based on reported info and customer order history.The lots are identified as, 0201480305 (customer reported), 0201385754, and 0201555647.A device history record (dhr) review was conducted for three potential lot numbers.All lot numbers belong to the same model identified.In addition, a sterilization process review was conducted for the lot numbers.Results: per the review of the dhr there were no reworks, special conditions, or related nonconformance reports (ncr's) for these lot numbers.All lots met the process specs, including the quality control acceptance criteria prior to release.The mfg date for lot number 0201480305 is june 2014 and the expiration date is may 31, 2017.Mfg date for lot number 0201385754 is march 2014 and the expiration date is 02/28/2014.The mfg date for lot number 0201555647 is august 2014 and the expiration is 07/31/2014.The sterilization process reviews were conducted on all three of the potential lot numbers and all of the sterilization certificates indicate that all three lots passed and were found to be in conformance with all specified requirements for sterile products.As the device was unavailable for analysis, no testing methods were performed.For this reason results cannot be obtained.Conclusions: the device was not returned to (b)(4) for eval.Therefore we are unable to determine the cause for the reported event.The dhr review of all three potential lot numbers indicate that the lots met all the quality and mfg specs, there were no nonconformances or reworks during product mfg.All sterilization process reviews conducted for the three potential lot numbers indicate that the lots passed and were found to be in conformance with all specified requirements for sterile products.If add'l info pertinent to this complaint is received, (b)(4) will submit a follow up report.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 investigations.

• Brand Name: T17X8, TUNNELER, DISPOSABLE, 17GA, 8IN
• Type of Device: ON-Q INTRODUCERS
• Manufacturer (Section D): HALYARD; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4337083
• MDR Text Key: 17278679
• Report Number: 2026095-2014-00259
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K063234
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/07/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/05/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 101373901
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/07/2014
• 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
• Treatment: SPINAL CORD STIMULATOR,; SUTURES,; STERI-STRIPS,; GENERATOR IMPLANTS,; DRUGS: LISINOPRIL,; FAMOTIDINE,; LEVOTHYRPXINE,; PERIPHERAL NERVE STIMULATOR LEADS,; DERMABOND,; MORPHINE; CITALOPRAM,
• Patient Outcome(s): Other
• Patient Age: 61 YR
• Patient Weight: 97