MAUDE Adverse Event Report: COOK INC MAXIMAL STERILE BARRIER BEDSIDE TRAY

Model Number N/A

Device Problems Fracture (1260); Material Separation (1562)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/31/2021

Event Type  Injury  

Manufacturer Narrative

Product code: oez.Pma/510(k) #: exempt.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 patient required a maximal sterile barrier bedside tray.During placement of the device, the catheter tore in the patient "around the 10cm mark".The patient then required an additional procedure to have a different central venous catheter placed.No other adverse effects were reported for this incident.Additional information regarding event and device details have been requested, but is currently unavailable.

Manufacturer Narrative

Additional information - b5, d6 - device was implanted for one week, d9.Rpn and lot number provided by customer do not match the reported complaint device.Device returned to cook is a spectrum dual lumen 5fr picc.Additional information has been requested but is currently 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 provided 28jun2021, it was reported that the device was in place for one week prior to the complaint event.The device was used with power injection.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.It was reported by the vascular access team nurse manager from crouse health hospital, inc that a ¿cook picc burst in a patient.¿ the exact device that was being used is unknown.It was reported that the complaint device was a ¿dual lumen rifampin and minocycline picc.The device had been implanted approximately one week before the event and had been used previously for power injection.The customer stated that the ¿burst¿ occurred around the 10 cm mark.The patient was reported to be ¿okay¿ after the event.Reviews of the documentation including the instructions for use (ifu) and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.One device was returned for evaluation in used condition.A 5mm rupture was observed approximately 8.5cm from the hub.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that there are process checks during the manufacturing process to identify defects that may lead to this failure.A review of the device history record (dhr) could not be conducted, due to the lack of lot information from the facility.Based on the device failure analysis and dmr, there is no indication the device was manufactured out of specification.As the lot number was unavailable, it is unknown if any non-conforming material in house or in the field.Cook also reviewed product labeling.The instructions for use (ifu) (ifu) t_upicabrmtt_rev1 states: ¿how supplied: upon removal from package, inspect the product to ensure no damage has occurred.¿ based on the information provided, examination of the returned product and the results of our investigation, a definitive cause for catheter rupture could not be established.The appropriate personnel have been notified.Per the 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.

Event Description

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

• Brand Name: MAXIMAL STERILE BARRIER BEDSIDE TRAY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer (Section G): COOK INC; 750 daniels way; bloomington IN 47404
• Manufacturer Contact: jason crouch ; 750 daniels way; bloomington, IN 47404 ; 8123392235
• MDR Report Key: 11968619
• MDR Text Key: 266868110
• Report Number: 1820334-2021-01486
• Device Sequence Number: 1
• Product Code: OEZ
• UDI-Device Identifier: 00827002208995
• UDI-Public: (01)00827002208995(17)211120(10)13600466
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 04/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/20/2021
• Device Model Number: N/A
• Device Catalogue Number: MSB-TRAY
• Device Lot Number: 13600466
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/01/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/14/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/03/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 76 YR
• Patient Weight: 59 KG