MAUDE Adverse Event Report: I-FLOW LLC ON-Q EXPANSION KIT: SILVER SOAKER; ELASTOMERIC PUMP

Model Number PM20-A

Device Problems Split (2537); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 09/29/2013

Event Type  Injury  

Event Description

Procedure: tah, bso.Cathplace: along side the mid abdomen.Per senior resident, the pt had two pump catheters alongside the mid abdomen.Upon removal, he pulled one catheter out without incident, when he pulled out the second catheter, it was about three inches shorter.It did not have the black tip; he suspected that it broke off inside the pt.It was reported they attempted to locate the catheter, and did not see it.The broken piece was initially saved at the bed side, but then discarded by a nurse.The pt was discharged home.It was reported that there was an additional attempt to remove the catheter which was unsuccessful and had to be removed under spinal anesthesia the catheter had adhered to scar tissue.

Manufacturer Narrative

Method: the device was reported to have been discarded and a lot number was not available.Results: as a device was not available for an evaluation, no methods were performed, therefore results cannot be obtained.Conclusion: the device was not returned to i-flow for evaluation, therefore we are unable to determine a cause for the reported event.

• Brand Name: ON-Q EXPANSION KIT: SILVER SOAKER
• Type of Device: ELASTOMERIC PUMP
• Manufacturer (Section D): I-FLOW LLC; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, suite 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 4009474
• MDR Text Key: 20772470
• Report Number: 2026095-2014-00124
• Device Sequence Number: 1
• Product Code: BSO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K051401
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 06/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/22/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: PM20-A
• Device Catalogue Number: 101353500
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/26/2014
• 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; Required Intervention