MAUDE Adverse Event Report: COOK INC MEDIUM PRESSURE CONNECTING TUBE

Model Number	G00040
Medical Device Problem Codes	Fluid/Blood Leak (1250); Leak/Splash (1354); Material Split, Cut or Torn (4008)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Common device name: dtl.Pma/510k #: exempt.This report includes information known at this time.A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
As reported, during a pulmonary angiogram a medium pressure connecting tube began to leak after the pressure injection caused a hole in the side of the device.The machine pressure was set at 800 (no units provided).It stated the pressure during the event was 797.Omnipaque was being injected at 30ml/s and 20ml/s.There was no change or impact on the patient care or outcome.No unintended part of the device remained inside the patient's body.No additional procedure was required due to this occurrence.No adverse effect was reported due to this occurrence.
Event or Problem Description
No new patient or event information to report.
Additional Manufacturer Narrative
Description of event: as reported, during a pulmonary angiogram a medium pressure connecting tube began to leak after the pressure injection caused a hole in the side of the device.The machine pressure was set at 800 (no units provided).It stated the pressure during the event was 797.Ominpaque was being injected at 30ml/s and 20ml/s.There was no change or impact on the patient care or outcome.Investigation ¿ evaluation.A visual inspection and functional testing of the returned device was conducted.A document based investigation was also performed including a review of complaint history, device history record, and quality control data.One used tube was received for investigation.The tubing was ruptured at the luer fitting end.The device was leak tested, and a leak was confirmed.No other damage was noted.Cook concluded that the device was manufactured within specification.A review of the device history record found no non-conformances related to the reported failure mode.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.A review of complaint history records shows no other complaints associated with the complaint device lot.The affected product does not come with an instructions for use, but the label on the product states the maximum pressure to be = 800psi.A review of relevant manufacturing documents was conducted.It was concluded that the device aspect in question was visually/functionally inspected by quality control, and no related gaps in production or processing controls were noted.Cook has concluded a component failure contributed to this incident.Per the quality engineering risk assessment, no further action is warranted.Cook will continue to monitor this device via the complaints database 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.

• Brand Name: MEDIUM PRESSURE CONNECTING TUBE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11267485
• Report Number: 1820334-2021-00234
• Device Sequence Number: 4997326
• Product Code: DTL
• UDI-Device Identifier: 00827002000407
• UDI-Public: (01)00827002000407(17)230924(10)13449956
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 03/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 09/24/2023
• Device Model Number: G00040
• Device Catalogue Number: DPT9.5-180-P-FM
• Device Lot Number: 13449956
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/11/2021
• Initial Date Received by Manufacturer: 01/25/2021
• Supplement Date Received by Manufacturer: 03/16/2021
• Initial Report FDA Received Date: 02/02/2021
• Supplement Report FDA Received Date: 03/24/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1