MAUDE Adverse Event Report: I-FLOW, LLC PROLONG CONTINUOUS NEEDLE & CATHETER SETS

Model Number PL18150TGC

Device Problems Stretched (1601); Split (2537); Torn Material (3024)

Patient Problem Foreign Body In Patient (2687)

Event Date 12/12/2013

Event Type  Injury  

Event Description

Drug/diluent: not applicable.Fill volume: not applicable.Flow rate: not applicable.Procedure: right foot arthrodesis.Cathplace: popiteal block.Date of surgery: (b)(6) 2013.A phone call was received from baxter product surveillance staff, reporting an i-flow catheter was broken.The lot number and model number were not known.Baxter received a catheter complaint from (b)(6) hospital on (b)(6) 2013.At that time, the complainant was not sure who was the manufacturer of the catheter.On (b)(6) 2013, the complainant contact baxter that the catheter was made by i-flow.It was reported that the infusion was completed without any issue.When removing the catheter, a knot of the catheter was noticed under the patient's skin.When further removal was attempted, the catheter broke.The catheter knot (broken segment of the catheter) was able to be removed by a mosquito (a small hemostat).There were no further issue after the broken segment was removed.Additional info received (b)(4) 2013: the incident happened 2nd day after surgery, catheter was described as being clear.The catheter was removed by an mda (anesthesiologist), per the pt's record, it mentioned that resistance was met during catheter removal.After the catheter was broken, the mda palpated a knotted catheter under the pt's skin.A small hemostat was used to remove the knotted catheter from the pt.The end black tip was identified in the knotted section.The catheter appeared very stretched out.The anesthesiologist reported the catheter might have be coiled up during insertion.The pt has been doing well after the catheter was removed he was discharged to a "swing-bed" on (b)(6) 2013.Model and lot number were unk.Additional info (b)(4) 2014: the complainant provided a photograph of an unused sample in order to obtain the model number of the device.The lot number is not valid as it is not related to the complaint sample.

Manufacturer Narrative

Method: it was reported that the device will be returned for an evaluation and investigation.As no lot number was reported, a review of the device history record (dhr) cannot be performed.Results: the evaluation and investigation are still in progress.Conclusions: at this time, i-flow is pending the return of the device for an evaluation.The investigation and evaluation are ongoing, once completed, a follow-up report will be submitted.

• Brand Name: PROLONG CONTINUOUS NEEDLE & CATHETER SETS
• Type of Device: CATHETER
• Manufacturer (Section D): I-FLOW, LLC; lake forest CA
• Manufacturer Contact: maria wagner ; 20202 windrow dr.; lake forest, CA 92630 ; 9495973957
• MDR Report Key: 3592968
• MDR Text Key: 4142872
• Report Number: 2026095-2014-00011
• Device Sequence Number: 1
• Product Code: CAZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102007
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Not Applicable
• Type of Report: Initial
• Report Date: 12/23/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/17/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: PL18150TGC
• Device Catalogue Number: 103277600
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 12/23/2013
• Was Device Evaluated by Manufacturer?: No
• 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: 52 YR
• Patient Weight: 74