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

Model Number PM020-A

Device Problem Break (1069)

Patient Problem Device Embedded In Tissue or Plaque (3165)

Event Date 08/06/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).Method: the device was received for analysis.A visual inspection was performed.The reporter was unable to provide a lot number; thus, the device history record (dhr) review cannot be conducted.Results: there are no testing results available as the investigation and evaluation are currently in progress.Conclusions: once the analysis and investigation are completed a follow-up report will be submitted.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.

Event Description

Procedure: knee replacement ((b)(6) 2015).Cathplace: posterior knee capsule.It was reported that a catheter break occurred upon removal with a piece retained inside the patient.The nurse was told to remove the catheter prior to a second planned knee surgery.The nurse met resistance and then used force to continued to pull until the catheter broke.The nurse notified the physician and at the time of this report, there was no plan to remove the retained piece of the catheter.The broken catheter sample is available for return.Additional information was received on 08/17/2015.It was reported that the patient did not express any discomfort at the time of the catheter removal.Approximately 4 inches of the catheter is retained inside the patient.There were no devices used to remove the catheter, only manual force was exerted.The catheter appeared stretched after removal.

Manufacturer Narrative

Method: a visual inspection, catheter tensile strength testing, photographic images and a microscopic inspection was performed on the returned device.Results: a visual inspection found that a silver-soaker catheter was returned not fully intact.It was missing the black catheter tip and the infusion segment.There is a kink approximately 8.3¿ distal to the catheters female hub, also a kink at the 1st marking.The diameter of the broken portion was measured to be 0.022¿.The non-attenuated part was measured to be 0.043¿.The silver-soaker catheter was examined under a microscope magnified and there were no signs of brittleness.Tensile strength testing was performed on the silver-soaker catheter.The result for the catheters mid-body segment was 12.160(lbf).The passing rate for the test is >2.8(lbf) at the infusion segment and >4.00 (lbf) for the mid-body segment.The tensile strength was not performed on the infusion segment because it was not returned.The catheter met specifications during the tensile strength test and no additional testing was performed.Conclusion: the investigation summary concludes that the silver-soaker catheter was received not fully intact, it was missing the black catheter tip and the infusion segment.Evidence revealed that stretching was observed where the breakage occurred.Tensile strength testing was performed on the mid-body segment and it met specifications.It was reported that there was some force applied after resistance was met when removing the catheter.They continued to pull and the catheter broke.The ifu and the technical bulletin state if catheter stretches stop, because continued pulling could break the catheter.Root cause was determined to be the incorrect use by the user as using excessive force >4.00(lbf) on the catheter at the mid-body segment >2.8(lbf) or at the infusion segment will cause it to break.The technical bulletin ( tips for preventing in-situ catheter breakage with the on-q* pain relief system, mk 00021) and instructions for use (on-q* catheters and introducers (14-60-602-0-04)) was sent to the customer with their closure letter.This incident has been included in our complaint handling database, which is actively monitored and trended.

• Brand Name: ON-Q CATHETER SILVERSOAKER 5 IN (12.5CM)
• 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-1b; fraccionamiento rubio; tijuana, b.c.
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 5040160
• MDR Text Key: 24515130
• Report Number: 2026095-2015-00221
• 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: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Followup
• Report Date: 08/06/2015

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: Health Professional
• Device Model Number: PM020-A
• Device Catalogue Number: 101353500
• Device Lot Number: ANP
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/19/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/28/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• 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): Other
• Patient Age: 59 YR