MAUDE Adverse Event Report: I-FLOW, LLC, ON-Q CATHETER SILVERSOAKER 7.5 IN (19CM); CATHETER, CONDUCTION, ANESTHETIC

Model Number PM050-A

Device Problems Leak/Splash (1354); Split (2537); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 05/25/2014

Event Type  malfunction  

Event Description

Procedure: catheter placement at ipsilateral rib fracture.Cathplace: patient's back.Date of procedure: (b)(6) 2014.The nurse reported a silversoaker was broken into 2 segments during patient use.The catheter was placed on (b)(6) 2014 and the incident happened on (b)(6) 2014.The patient is a (b)(6) female who sustained a fall resulting in three fractured ribs ((b)(6)) on the left side.Two silversoaker catheters were placed on the patient's back for pain control.One of the catheters was placed 3 cm lateral to the spine.Another was placed 6 cm lateral to the spine.A nurse reported that she had noticed something was leaking when she walked the patient to the bathroom.The catheter closer to the spine (3 cm lateral) was broken outside of the dressing.The nurse contacted the physician, who came to remove the broken catheter and replaced it with a new catheter.The catheter did not break inside the patient and the broken edges were clean cuts without stretches.The patient is doing well with no injuries.The broken catheter was thrown away.Information from this incident will be included in our product complaint and mdr trend reporting system.Additional investigation may arise from ongoing analysis, trend information, or other analysis as appropriate.

Manufacturer Narrative

Method: customer discarded the suspect part and will not be returning the product to i-flow for investigation.A review of the device history record (dhr) was conducted for the lot number provided.Results: no device was available for an evaluation.Per the dhr review the lot meet all manufacturing specifications at release.A historical review was performed for 2.5 years and there were no similar incidents reported for model pm050-a.See scanned page.Conclusions: the device was not returned to i-flow for evaluation and analysis, therefore we are unable to determine a cause for the reported event.If additional information pertinent to this event becomes available, i-flow will submit a follow-up report.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 CATHETER SILVERSOAKER 7.5 IN (19CM)
• Type of Device: CATHETER, CONDUCTION, ANESTHETIC
• Manufacturer (Section D): I-FLOW, LLC,; irvine CA
• Manufacturer Contact: maria wagner ; 43 discovery, ste 100; irvine, CA 92618 ; 9499232324
• MDR Report Key: 3960699
• MDR Text Key: 4561980
• Report Number: 2026095-2014-00084
• 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: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 05/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/20/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2016
• Device Model Number: PM050-A
• Device Catalogue Number: 101354100
• Device Lot Number: 0201215393
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/25/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/01/2013
• 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 Age: 88 YR