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Common device name: not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report.Pma/510(k): not available as this device is not sold in the us, but it is considered to be clinically similar to a device that is, thus prompting this report.(b)(4).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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It was reported that a break was noticed in the line of a redo single lumen tpn catheter.The patient's father was flushing the picc line at home when he noticed saline spraying out from a break in the line.The line was cleaned, clamped, and covered before the patient and their father presented at the hospital.The line was originally implanted at bc children's hospital but the patient went to ach in calgary to treat the break as they were too far away from bc children's hospital.As the patient was not at their normal facility, the lot number for the tpn catheter is unknown.Upon inspection initially in the emergency department by a unit 1 rn certified in line repair, a break larger than 1 cm was noted along the length of the line, in the thicker part of the line.The repair was completed by the unit 1 rn, on unit 2 where the patient was admitted.The family came with a repair kit.The patient's activity level was described as active.No other adverse effects have been reported.Additional information regarding patient and event details has been requested but is not currently available.
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Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Investigation - evaluation it was reported by alberta children's hospital that a patient came to an emergency ward as when the patient's father was flushing a tpn line, he noticed the break in the line as saline sprayed.They cleaned, clamped, and covered the device.Upon inspection initially in the emergency department by a unit 1 rn certified in line repair, a >1cm break was noted along the length of the line, in the thicker portion.A repair was completed by a unit 1 rn, on unit 2 where the patient was admitted.The family came with a repair kit (part number c-rhcs-3.0).The patient was described to be active.A review of the complaint history, instructions for use (ifu), and quality control, as well as a visual inspection of the returned device, was conducted during the investigation.One redo single lumen tpn catheter set was returned to cook for evaluation.Upon visual inspection, a split in the catheter was viewed near the hub.Complete separation of the material was noted.Cook has concluded that the device was manufactured to specification.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the device history record (dhr) and a database search were unable to be completed due to a lack of lot information from the user facility.As adequate inspection activities have been established and no other lot related evidence is available, cook has concluded that there is no evidence that nonconforming product exists either in house or in field.Cook also reviewed product labeling.The redo single lumen tpn catheter set is supplied with ifu c_t_tpn_rev9.Pdf, which includes the following relevant to this 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 device, and the results of the investigation, a definitive root cause for this event could not be established.The appropriate personnel have been notified.Cook will continue to monitor for similar complaints.Per the quality engineering risk assessment no further action is required.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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