MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET

Model Number G07933

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Sepsis (2067); No Code Available (3191)

Event Date 06/12/2020

Event Type  Injury  

Manufacturer Narrative

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.Initial reporter customer (person): (b)(6).Reporter 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.(b)(4).This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.

Event Description

It was reported that a patient developed sepsis after a redo single lumen tpn catheter was placed.The tpn catheter was removed and replaced with a like device (gpn: g07933, lot # 13007915).The patient was described as, "independent and following the st marks protocol." events that include another instance of sepsis and two separate split lines have been reported for the same patient that reference the patient identifier: (b)(6).Additional information regarding the device and event have been requested, but are unavailable at the time of this report.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown or unavailable.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.

Event Description

In additional information received on 25nov2020, it was reported that antibiotics were used to treat the occurrence of sepsis.The only pre-existing condition that would have made the patient pre-disposed for to a higher risk of infection was short bowel syndrome.The patient was described as self caring at the time sepsis occurred.The device was placed in the left internal jugular for tpn administration.The failure occurred during treatment.When not in use, the catheter was flushed with and locked an 0.9% saline solution.A presumed 10ml syringe was used for flushing.A needleless injector cap was used, however no anti-tamper device was used.The device was initially secured with sutures, however griplok was later used.Patient activity level was described as "active.".

Event Description

No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.

Manufacturer Narrative

Investigation / evaluation: it was reported by sister (b)(6) form the radiology department of (b)(6) hospital (b)(6) 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 (b)(6) 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: 9673773) that was removed on (b)(6) 2020 due to sepsis.The patient was self-caring at the time of the event.As a result of the sepsis, the redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number: 9673773) was removed.It was replaced with redo single lumen tpn catheter set (rpn: c-tpns-6.5-90-redo, lot number: 13007915.Antibiotics were administered to treat the sepsis.Compliance to the maintenance of this device was assumed to be in accord with ¿st.Marks 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 of the device was conducted during the investigation.The complaint device was not returned for evaluation; therefore, no physical examinations could be conducted.However, 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: 9673773 found no relevant nonconformances that could have contributed to the reported failure mode.It should be noted there were no other complaints associated with this lot number.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 have been received from the field from other customers, 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: precautions: extreme caution must be used in placement monitoring.Suggested catheter maintenance: strict aseptic technique must be adhered to while using and maintaining catheter.How supplied: supplied sterilized by ethylene oxide gas in peel-open packages.Intended for one-time use.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile.Store in a dark, dry, cool place.Based on the information provided, no 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 catheter maintenance or patient pre-existing condition/co-morbidities as a cause 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.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10868375
• MDR Text Key: 217161523
• Report Number: 1820334-2020-02153
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002079335
• UDI-Public: (01)00827002079335(17)220515(10)9673773
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Type of Report: Initial,Followup,Followup
• Report Date: 02/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/15/2022
• Device Model Number: G07933
• Device Catalogue Number: C-TPNS-6.5-90-REDO
• Device Lot Number: 9673773
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Life Threatening; Required Intervention