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

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).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: c-section.Cathplace: abdomen.It was reported that a catheter break occurred inside a patient during use.The device is available for return.Additional information was received on 08-25-2015.It was reported that there was approximately 4mm of the catheter retained inside the patient.The decision was made to not remove the catheter.Additional information was requested, however is not available at this time.

Manufacturer Narrative

Method: a visual inspection, catheter tensile strength test, a microscopic inspection and photographic inspection was performed on the returned device.Results: a visual inspection found the silver-soaker catheter was returned not fully intact, the infusion segment of the catheter was missing.Inspected the catheter for signs of brittleness and none were found.The catheter was measured with a ruler and was approximately 44 inches long.The catheter was visibly stretched as it exits the luer connection.The catheter attenuation continued to approximately 14 inches where there was a visible kink.Attenuation was present on the catheter for the remaining length.The catheter was measured at approximately 33.5 inches and the diameter was 0.027 inches.The distal tip of the remaining catheter portion was measured and the diameter was 0.027 inches.The distal end of the catheter was examined under magnification and found signs of it being stretched.Tensile strength testing was performed on the silver soaker catheter and the tensile strength on the mid-body segment was 11.48 lbf which is within specification.The infusion segment was not received back and therefore testing on the infusion segment could not be performed.The passing rate for the test is >2.8(lbf) at the infusion segment and >4.00 (lbf) for the mid-body segment.Conclusion: the investigation summary concludes that the silver soaker catheter was broken shortly before the infusion segment mark.Attenuation was visible along the entire catheter.The end of the catheter at the break shows signs of stress when viewed under a microscope; thus, indicating it was pulled.Tensile strength was performed on the mid-body segment and it met specifications.A copy of the technical bulletin (tips for preventing in-situ catheter breakage with the on-q* pain relief system (mk 00021)) and a copy of the instructions for use (on-q* catheters and introducers (14-60-602-0-04) was provided to the customer along with a copy of their closure letter.Information from this incident has been included in our product complaint trend reporting systems for monitoring, tracking and trending purposes.

• Brand Name: ON-Q CATHETER SILVERSOAKER 5 IN (12.5CM)
• Type of Device: ELASTOMERIC PUMP
• 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: 5043417
• MDR Text Key: 24650654
• Report Number: 2026095-2015-00220
• 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: Physician
• 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: ASKU
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/25/2015
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/31/2015
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/18/2015
• 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