MAUDE Adverse Event Report: HALYARD - IRVINE ON-Q PUMP SOAKER 2.5IN (6.5CM): 270ML, DUAL 2+2ML/HR; ELASTOMERIC PUMP

Model Number PM015

Device Problem Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 02/28/2015

Event Type  Injury  

Event Description

Procedure: c-section ((b)(6) 2015) cathplace: abdominal region (c-section wound) date of initial information: (b)(6) 2015 a medsun medwatch report was received with information that a catheter broke inside of a patient during removal by the nurse.The nurse noted that the "tubing seemed short and the black catheter tubing tip was not present.The end of the catheter appeared to be shredded".There was approximately 40cm of the catheter retained in the patient.Surgical exploration of the c-section wound and subfascial space was needed to locate and remove the missing piece of the catheter.The incident occurred in the hospital prior to discharging the patient.The sample is available for evaluation.Additional information was received on (b)(6) 2015.Sample will not be released at this time, however pictures can be provided.Additional information was received on (b)(6)2015.The catheter was surgically removed on (b)(6) 2015.The patient's condition was reported as fine.Resistance was met when the nurse attempted to remove the catheter and after repositioning the patient.The catheter appeared to have a clean cut.

Manufacturer Narrative

User facility report #(b)(6) is attached.(b)(4).Method code: actual device not evaluated methods: actual device was not received for an evaluation and investigation; however, photographs were provided for inspection.In addition a review of the device history record (dhr) was conducted for the reported model and lot number.Results: the photographic inspection indicates the catheter was broken at the proximal end.The dhr was reviewed for the lot number of the manufactured unit.There were no reworks, special conditions, or related nonconformance reports (ncrs) for this lot.The lot met the process specifications, including the quality control acceptance criteria prior to release.The instructions for use (ifu)(14-60-602-0-04) includes information to prevent catheter breakage during removal.Per the ifu, "catheter removal remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter.Remove dressing and loosen the adhesive strips at catheter site (figure 10 on page 2).Grasp catheter close to skin and gently pull to remove.The catheter should be easy to remove and not painful.Do not tug or quickly pull on catheter during removal (figure 11 on page 2)." the ifu further specifies, "cautions: if resistance is encountered or catheter stretches, stop.Continued pulling could break the catheter.¿ it¿s advisable to cover the site with warm compresses, and wait 30 to 60 minutes, and try again.The patient¿s body movements may relieve the catheter to allow easier removal.¿ for additional information refer to the technical bulletin: tips for preventing in-situ catheter breakage with the on-q* system.¿ do not cut or forcefully remove catheter.¿ after removal, check distal end of catheter for black marking to ensure entire catheter was removed (figure 12 on page " conclusions: the device was not returned to halyard for evaluation, therefore we are unable to determine the cause for the reported event.However, photographic inspection indicates that the catheter was broken at the proximal end.It was reported that resistance was met when the nurse attempted to remove the catheter.Based on the information provided, the operator's technique or use environment may have caused or contributed to the reported incident.However, we are unable to evaluate the root cause for the reported incident since we did not receive the device for analysis.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.

• Brand Name: ON-Q PUMP SOAKER 2.5IN (6.5CM): 270ML, DUAL 2+2ML/HR
• 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. 2211 6; MX 22116
• Manufacturer Contact: maria wagner ; 43 discovery; suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4760225
• MDR Text Key: 5949917
• Report Number: 2026095-2015-00145
• Device Sequence Number: 1
• Product Code: MEB
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PK063530
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Health Professional,User Facility,Company Representative
• Reporter Occupation: Attorney
• Type of Report: Initial
• Report Date: 04/13/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2017
• Device Model Number: PM015
• Device Catalogue Number: 101363500
• Device Lot Number: 0201642653
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Event Location: Other
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/06/2014
• 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: TEGADERM DRESSING; STERI-STRIPS
• Patient Outcome(s): Other
• Patient Age: 29 YR