MAUDE Adverse Event Report: COOK INC

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem No Code Available (3191)

Event Date 01/19/2021

Event Type  Injury  

Manufacturer Narrative

Initial reporter occupation: manager.(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 an unknown cook spectrum picc device broke.The device was implanted on (b)(6) 2021.Medicines administered through the device potentially include fosphenyoin and acyclovir.As a result of the break, the patient had another device placed ("rewired") and was reported to have "did well".Additional information regarding the patient, device, and event has been requested but is not available.

Event Description

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

Manufacturer Narrative

Investigation - evaluation.It was reported that an unknown cook spectrum picc device broke.The customer assumes it was an issue concerning the hub.Cook became aware of this event on 22jan2021 upon being notified by children's hospital of philadelphia.The patient reportedly experienced no adverse effects as a result of this incident.The investigation was performed under the assumption that the failure mode was hub leakage and the device was rpn: upicds-5.0-ct-40nt-abrm-1111.A review of the complaint history, instructions for use (ifu), and quality control of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be performed.However, 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 design history file (dhf) showed that this device is both safe and effective for its intended use.A review of the device history record (dhr) was unable to be completed due to a lack of lot information from the user facility.Based on the available information, cook has concluded that the device was manufactured to specification and that there is no evidence suggesting nonconforming product exists either in house or in field.Cook also reviewed product labeling.Instructions for use (ifu) document t_upicabrmtt_rev1 [cook spectrum turbo-ject peripherally inserted central venous catheters with micropuncture peel-away introducers] is packaged with the assumed rpn of the device.The product ifu states the following in consideration of the reported failure mode: ¿intended use the cook spectrum turbo-ject picc is indicated for multiple injections of contrast media through a power injector.The maximum pressure limit setting for power injectors used with the spectrum turbo-ject picc may not exceed 325 psi and the flow rate may not exceed the maximum flow rate indicated, as shown on the following table.Warnings the safe and effective use of spectrum turbo-ject picc lines with power injector pressures set above 325 psi has not been established.Do not power inject if maximum injection rate cannot be verified to meet limit printed on catheter hub or extension tube.To safely use spectrum turbo-ject picc lines with a power injector, the technician/health care professional must verify: the catheter lumen has ¿ct¿ on the hub to indicate the lumen is power injectable.Prior to use that the maximum pressure limit is set at or below 325 psi and that the maximum flow rate is at or below that which is listed on the catheter.Dynamic and static pressure test results are shown in the following table.How supplied upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, no product returned, and the results of our investigation, a definitive root cause for this event was unable to be established.Appropriate measures have been initiated to address this failure mode.A capa is currently in progress to further investigate this failure mode with this device/device family.The appropriate personnel have been notified.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.

• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11287045
• MDR Text Key: 230546252
• Report Number: 1820334-2021-00264
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): Y
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 07/06/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/22/2021
• Initial Date FDA Received: 02/05/2021
• Supplement Dates Manufacturer Received: 07/01/2021
• Supplement Dates FDA Received: 07/06/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 8 YR