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Model Number KIT, POWER PAC II, VEN, PU, 2.6MM, UL 1/EA |
Device Problems
Fluid/Blood Leak (1250); Defective Component (2292); Connection Problem (2900)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/11/2020 |
Event Type
malfunction
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Event Description
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Information received a smiths medical implantable ports|deltec power port-a-cath ii ports was observed leaking around distal connection to port.A new device was inserted on patient.No patient adverse events reported.
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Manufacturer Narrative
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Investigation completed on a smtihs medical implantable ports| deltec power port-a-cath ll ports.When visually inspecting device under normal lighting from a distance of 12" to 16" revealed a fissure detected on the catheter close to port.Mitigation revealed on other lots that the port a cath passed 100 % on inspections prior to release.The root cause was believed the incident of crack occurred after leaving manufacture.Complaint could not be verified as damage was believed to occur after manufacturing process.Due to previous complaints quality engineer on (b)(6) 2020 was made aware of complaint.Updated fields.A 1, b 1, b 3, b 4, b 5, d 10, g 7, h 1, h 2, h 3, h 6, h 10.
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Event Description
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Investigation completed on a smiths medical implantable ports|deltec power port-a-cath ii ports.Device evaluation in h 10.
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Manufacturer Narrative
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Visual inspection of the returned sample identified a fissure on the catheter close to the port.Based on manufacturing controls, it was improbable that this type of damage originated during the manufacturing process.The most probable cause was that damage occurred after the product left the manufacturing facility.The instructions for use (ifu) warns the user of the following failure to suture the portal in place or tunnel the catheter to the portal when appropriate, may cause catheter flexing which could result in catheter occlusion or catheter fragmentation, fracture or shearing.Do not withdraw blood from or infuse medication into any area of the arm where the system is located unless you are using the portal.Do not measure the patient's blood pressure on this arm.Failure to observe these restrictions could cause inadvertent catheter puncture, catheter occlusion, or other catheter damage.Avoid medial catheter placement into the subclavian vein through percutaneous technique.This placement could lead to catheter occlusion, damage, rupture, shearing or fragmentation due to compression of the catheter between the first rib and clavicle.Do not use any instruments to assist in seating the connector, do not use forceps or instruments with teeth or sharp edges to attach the catheter to the portal, as this may damage the catheter and could result in embolization of all or part of the catheter in system leakage.For non-power injection applications, do not exceed a pressure of 40 pounds per square inch (psi) when flushing through the system.Damage due to excessive pressure may include, but is not limited to, catheter rupture or fragmentation with possible embolization, or drug extravasation.The root cause of this failure was unable to be determined.This remediation mdr was generated under protocol b10009406, as a result of warning letter cms# 617147.
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Search Alerts/Recalls
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