MAUDE Adverse Event Report: COOK INC HIGH PRESSURE BRAIDED CONNECTING TUBE

Model Number G00060

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/24/2020

Event Type  malfunction  

Manufacturer Narrative

Common name & product code: dtl adaptor, stopcock, manifold, fitting, cardiopulmonary bypass.(b)(6).Pma/510(k) number: exempt.A follow-up report will be submitted should additional relevant information become available.

Event Description

As reported, prior to use during an unknown procedure, a high pressure braided connecting tube leaked at the connection site.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.

Event Description

No new patient or event information to report.

Manufacturer Narrative

Description of event: as reported, prior to use during an unknown procedure, a high pressure braided connecting tube leaked at the connection site.The patient did not require any additional procedures due to this occurrence.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.Investigation ¿ evaluation.A document based investigation was performed including a review of complaint history, device history record, documentation, manufacturing instructions, quality control data, and specifications.The complaint device was not returned; therefore, no physical examinations could be performed.However, a document based investigation evaluation was performed.There is no evidence to suggest the product was made out of specification.A search of cook¿s inventory determined that all devices from the complaint lot were already out of cook¿s control and thus a representative device from the lot could not be examined.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.There is no ifu provided with this device.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.It is most likely that the device was inadvertently damaged during either shipping or storage.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: HIGH PRESSURE BRAIDED CONNECTING TUBE
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 10936318
• MDR Text Key: 219548914
• Report Number: 1820334-2020-02221
• Device Sequence Number: 1
• Product Code: DTL
• UDI-Device Identifier: 00827002000605
• UDI-Public: (01)00827002000605(17)230304(10)13027856
• Combination Product (y/n): N
• 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: 03/22/2021

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
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: G00060
• Device Catalogue Number: HPCT8.8-120-M-FM
• Device Lot Number: 13027856
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 11/25/2020
• Initial Date FDA Received: 12/02/2020
• Supplement Dates Manufacturer Received: 03/11/2021
• Supplement Dates FDA Received: 03/22/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1