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Pma/510k: this information is unavailable as this device is not actively sold in the u.S.; however, this device meets the criteria for same/similar to another device manufactured by cook that is sold in the u.S., thus prompting this report.First name: b)(6).This report includes information known at this time.A follow-up report will be submitted should additional relevant information become available.
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Additional information regarding event details was received on (b)(6) 2020.It was reported the catheter was partially separated on the tubing between the suture rings on the device and the catheter hub.The catheter was placed for the intra venous (iv) infusion of sodium chloride (nacl 0.9% 1000 ml) + potassium chloride (kcl )+ magnesium sulfate.The medications were to be infused while the patient was at home.The catheter was placed using the right translumbar access on (b)(6) 2020.The device was secured for the first 8 weeks with a catheter securement device and a sterile adhesive wound dressing.On (b)(6) 2020 the device was only secured with a sterile adhesive wound dressing.The patient was reported to be mobile.A needless connector was used with the catheter.The central venous catheter was locked with 1.5 cc central venous access device locking solution (anti-microbial, anti-biotic, anti-coagulation) when not in use.The catheter was flushed with 10cc of saline solution.After the separation occurred on (b)(6) 2020, the device was repaired with a cook repair kit.Upon investigation of the returned device for this complaint, it was found that the silicone cover had separated from the winged fitting.An additional complaint was opened to cover that failure mode.As both complaints concern the same device, both issues will be reported under mdr#1820334-2020-01626.
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Investigation ¿ evaluation.It was reported by uz leuven that a tpn catheter from a redo single lumen tpn catheter set (part number c-tpns-6.5-90-redo , lot number unknown) was torn where the catheter is sutured to the patient.It was reported the catheter was partially separated on the tubing between the suture rings on the device and the catheter hub.The catheter was placed for the intra venous (iv) infusion of sodium chloride (nacl 0.9% 1000 ml) + potassium chloride (kcl )+ magnesium sulfate.The medications were to be infused while the patient was at home.The catheter was placed using the right translumbar access on (b)(6) 2020.The device was secured for the first 8 weeks with a catheter securement device and a sterile adhesive wound dressing.On (b)(6) 2020 the device was only secured with a sterile adhesive wound dressing.The patient was reported to be mobile.A needless connector was used with the catheter.The central venous catheter was locked with 1.5 cc central venous access device locking solution (anti-microbial, anti-biotic, anti-coagulation) when not in use.The catheter was flushed with 10cc of saline solution.After the separation occurred on (b)(6) 2020, the device was repaired with a cook repair kit (part number c-rhcs-6.5 lot.13041344).Upon investigation of the returned device for this complaint, it was found that the silicone cover had separated from the winged fitting.An additional complaint was opened to cover that failure mode.As both complaints concern the same device, both issues will be reported under mdr#1820334-2020-01626.A review of the complaint history, instructions for use (ifu), quality control and specifications, as well as a visual inspection of the returned device were conducted during the investigation.The complaint device was returned for evaluation.The device examination found the silicone cover has separated from the winged fitting.Additionally, a hairline split is visible under magnification with no signs of previous leakage.The split is where the catheter transitions between the catheter tubing and the reinforced section of the catheter.The distal tip point of separation is not jagged.A visual exam also noted the catheter has previously been repaired.Additionally, a document based investigation evaluation was performed.A review of the device master record found that proper procedures are in place to identify and prevent this failure mode prior to device distribution.A review of the design history file found that the risks associated with the devices are acceptable when weighed against the benefits.A review of the device history record and a search for additional complaints could not be completed as the lot number was not provided.A 2nd complaint, also reported under this mdr reference #, was opened in relation to this complaint for the clear silicone tubing that was observed to be separated from the winged fitting that was identified during the device failure analysis.There is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: warnings: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately.Precautions: silicone catheter are not designed for power injection.Catheter rupture may occur.Use of a 10ml syringe or larger will reduce the risk of catheter rupture.Suggested catheter maintenance: after catheter placement and prior to use, tip position and lumen patency should be confirmed by free aspiration of venous blood.If blood is not freely aspirated, catheter tip position should be immediately reevaluated by the physician.If catheter is not to be used immediately, its lumen should be drip maintained by continuous saline or heparinized saline drip or locked with heparinized saline solution.Normal saline lock is permissible if utilizing the clc000 injection cap.Catheter heparinization should be determined by institutional protocol and clinical judgement.Heparin concentration of 10 units/ml to 100 units/ml have been reported adequate to maintain lumen patency, catheter lock should be reestablished after every use or at least every 24 hours if unused.Before using catheter lumen already locked with heparin, lumen should be flushed with twice the indicated lumen volume using normal saline.Lumen should be flushed with normal saline between administration of different infusates.After use, lumen should again be flushed with twice the indicated lumen volume using normal saline before reestablishing heparin or saline lock.Strict aseptic technique must be adhered to while using and maintaining catheter based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause for failure was not established.The appropriate personnel have been notified.Per the quality engineering risk assessment, no further action is required.Cook will continue to monitor for similar complaints.This report is required by the fda under 21 cfr part 803 and is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement contained herein is intended to be an admission that any cook device is defective or malfunctioned, that a death or serious injury occurred, nor that any cook device caused, contributed to, or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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