MAUDE Adverse Event Report: COOK INC REDO SINGLE LUMEN TPN CATHETER SET; FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS

Catalog Number C-TPNS-3.0-65-REDO

Device Problem Material Puncture/Hole (1504)

Patient Problem Unspecified Infection (1930)

Event Date 11/27/2018

Event Type  Injury  

Manufacturer Narrative

Additional information: patient information - the patient (b)(6) years of age weighing (b)(6) kg.Device return: some part(s) of the device will be returned for evaluation.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 a redo single lumen tpn catheter set was used to repair a cook catheter delivering tpn and iron infusions.The cook catheter was said to have "popped" on (b)(6) 2018 during a saline flush, which caused a hole.The line was locked with heparin and a culture was taken.The culture tested positive for infection and antibiotic treatment was given.As reported, the patient did not require an additional procedure to replace the line as the line was repaired with the repair kit.

Manufacturer Narrative

Blank fields on this form indicate the information has previously been reported, is unknown or is unavailable.Additional information/corrected data: b5-after further review of the record it was determined that it should be noted, the medical profession had flushed the device with 9 ml of saline in a 10 ml syringe and that no clotting was identified at the time of the event.Additional information: device evaluation: one device returned to manufacturer for investigation.Part of the complaint device was returned that included the section of the device that failed.The remaining portion of the device remained indwelling the patient as it was reported to still be in use with the addition of a repair kit.Investigation results: visual exam notes tubing has pulled away at hub.To conclude, the device was returned with the silicone hub broken.Additionally, a document based investigation evaluation was performed.Investigation.A document-based investigation reviewed the following: complaint history, device history record, instructions for use, and quality control specifications.A review of relevant manufacturing documents was conducted.It was concluded current controls for manufacturing and quality control are in place to assure functionality and device integrity prior to shipping.A review of the device history record of the finished product and components show no nonconforming events that could contribute to this failure mode.A complaint history search revealed that there were no other reported complaints for this lot number.Per the ifu: indications for use.Cook tpn redo catheters and sets are used for administration of parenteral nutrition, chemotherapy, other therapeutic drugs, and blood.The "redo" suffix on the order number indicates that the cuff is 5 cm distal to the suture rings.Warnings: if lumen flow is impeded, do not force injection or withdrawal of fluids.Notify the attending physician immediately.Precautions: extreme caution must be used in placement and monitoring.Silicon catheters are not designed for power injection.Catheter rupture may occur.Use of a 10 ml syringe or larger will reduce the risk of catheter rupture.Clinical assessment: a clinical assessment was carried out that could not establish a cause.The clinical assessment did identify possible causes of product handling, medical procedure, device maintenance, device repair, patient environment, device failure and/or manufacturing related causes.Due to the young age of the patient, the clinical assessor identified that the would likely lack safety awareness surrounding the picc line.The clinical assessment also noted that the pic line breaking or the repair could have contributed to the positive culture that resulted in antibiotic treatment.Conclusion: based on the information provided, examination of the returned product, and the results of our investigation, a definitive root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed for similar complaints.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

No new event description information to report at this time.

• Brand Name: REDO SINGLE LUMEN TPN CATHETER SET
• Type of Device: FOZ CATHETER, INTRAVASCULAR, THERAPEUTIC, SHORT-TERM LESS THAN 30 DAYS
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8192167
• MDR Text Key: 131338646
• Report Number: 1820334-2018-03714
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00827002079601
• UDI-Public: (01)00827002079601(17)210720(10)9005428
• Combination Product (y/n): N
• PMA/PMN Number: K950118
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 02/28/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/20/2021
• Device Catalogue Number: C-TPNS-3.0-65-REDO
• Device Lot Number: 9005428
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/03/2019
• Date Manufacturer Received: 02/06/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 6 YR
• Patient Weight: 19