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Date of event: event occurred sometime in (b)(6) 2020.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.Customer (person): line 2: carylon house.Postal code: (b)(6).Phone: (b)(6).Occupation: interventional radiology/ vascular access team lead 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.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.This report is required by the fda under 21 cfr part 803.This report is based on unconfirmed information submitted by others.Neither the submission of this report nor any statement made in it is intended to be an admission that any cook device is defective or malfunctioned; that a death or serious injury occurred; or that any cook device caused or contributed to; or is likely to cause or contribute to a death or serious injury if a malfunction occurred.
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Additional information: b5, h6 - device code.Investigation ¿ evaluation.It was reported by sister (b)(6) form the radiology department of (b)(6) hospital (nhs trust), truro, united kingdom that the patient had a cut line.The patient was reported to have been diagnosed with short bowel syndrome.The indication for placement of the device was total parenteral nutrition (tpn) administration.The patient had relocated and first came to royal cornwall hospital on (b)(6) 2020.The patient has had several lines placed and then experienced issues.On (b)(6) 2020 the previously placed line redo single lumen tpn catheter set (rpn: unknown, lot number unknown) was removed due to sepsis.A new line, redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number 9673773) was placed.The redo single lumen tpn catheter set (rpn: unknown, lot number unknown) was not available for device inspection by the manufacturer.This event is captured in the report with report reference #: 1820334-2020-02152.On (b)(6) 2020 the redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number 9673773) was removed due to sepsis.It was replaced with redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number 13007915) the removed line was not available for device inspection by the manufacturer.This event is captured in the report with report reference #: 1820334-2020-02153.On (b)(6) 2020 the patient had cut their line (redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number 13007915).It was removed and replaced with a redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number 13005095).The removed line was not available for device inspection by the manufacturer.This event is captured in the report with report reference #: 1820334-2020-02005 on (b)(6) 2020 the line redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number 13005095) was reported to have split and was replaced with a vygon line.The device was returned to the manufacturer for device inspection.This was captured in report reference #: 1820334-2020-02006.The complaint device for this complaint is the redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number 13005095) that was reported to have split and was later discovered that the winged fitting had separated from the silicone cover.The device was placed in the right internal jugular vein on (b)(6) 2020.It was discovered during treatment on (b)(6) 2020 that the line had split.It was removed and replaced with a vygon line.Compliance to the maintenance of this device was assumed to be in accord with ¿(b)(6) protocol.¿ the patient was self-caring prior to the event.A review of documentation including the complaint history, device history record, 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 for evaluation.A visual examination noted that the silicone cover had come loose from the wing fitting.A leak test identified a split in the catheter that was at the distal end of the tape that had been wrapped around the catheter.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) found that sufficient controls are in place for the reported failure mode.A review of the device history record (dhr) for lot 13005095 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted that one other complaint was found for this lot, which captures the second failure mode in this complaint device.Because there are no related non-conformances, adequate inspection activities have been established, there is objective evidence that the dhr was fully executed, and no other lot related complaints that have been received from the field, it was concluded that there is no evidence that nonconforming product exists in house or in field.The instructions for use (ifu), provides the following information 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 catheters are not designed for power injection.Catheter rupture may occur.Use of 10ml syringe or later will reduce the risk of catheter rupture.Suggested catheter maintenance: 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, examination of the returned product and the results of our investigation, a definitive root cause for the failure could not be established.Cook was unable to rule out manufacturing, device maintenance, patient tampering with device, inadvertent tension placed on the device as a result of patient movement/activity/adl¿s, or excessive force of fluids through an obstructed lumen as possible causes of this event.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.We 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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