MAUDE Adverse Event Report: I-FLOW, LLC ON-Q CATHETER

Device Problem Split (2537)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/14/2014

Event Type  Injury  

Event Description

Procedure: total abdominal hysterectomy.Cathplace: top of the peritoneum.Surgery date: (b)(4) 2014.It was reported that an on-q catheter broke inside of a pt upon removal.The catheter was placed on toper of the peritoneum post total abdominal hysterectomy.The surgeon did not encounter any difficulty inserting the catheter and the catheter was not sutured through.The catheter was in place for 2 days.Upon removal, the resident was met with a lot of resistance, causing the catheter to stretch thin and break.The length of catheter left inside the pt was unk.There was no medical intervention related to the incident; as the retained segment of the catheter was not removed.The pt is currently stable and "fine." additional information was requested, but is not available at this time.

Manufacturer Narrative

Method: the device was reported not to be available for return.The model and lot number were unavailable, therefore a review of the device history record (dhr) could not be conducted.Results: as the device and lot number were unavailable for analysis, no methods were performed.For this reason results cannot be obtained.Conclusions: the device was not returned to i-flow for evaluation, therefore we are unable to determine a cause for the reported event.It was reported that resistance was met when removing the catheter, this may have played a factor in the breakage.Our clinical nurse specialist e-mailed the surgeon our technical bulletin entitled: "tips for preventing in-situ catheter breakage with the on-q post-op pain relief system." the directors for use (dfu) for catheter removal states: remove catheter as soon as infusion is complete to reduce risk of infection and difficulty removing catheter.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.Cautions: if resistance is encountered or catheter stretchers, stop.Continued pulling could break the catheter.It's advisable to wait 30 to 60 minutes and try again.The pt's body movements may relieve the catheter to allow easier removal.If catheter is still difficult to remove, an x-ray is recommended.Do not cut or forcefully remove catheter.After removal, check distal end of catheter for black marking to ensure entire catheter was removed.If additional information pertinent to this event becomes available, i-flow will submit a follow-up report.

• Brand Name: ON-Q CATHETER
• Type of Device: CATHETER
• Manufacturer (Section D): I-FLOW, LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery; ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3949168
• MDR Text Key: 4535331
• Report Number: 2026095-2014-00107
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 06/14/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/04/2014
• 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
• Patient Outcome(s): Other
• Patient Age: 44 YR