MAUDE Adverse Event Report: COOK INC SINGLE LUMEN PRESSURE MONITORING SET; DQY CATHETER, PERCUTANEOUS

Model Number	N/A
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/23/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(6).Occupation: nursing supervisor.Pma/510(k) #: preamendment.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
It was reported that the needle of a single lumen pressure monitoring set was not hollow.As the device was being placed, the user went to thread the needle, but found that it was not able to be passed through.It was then discovered that there was not a hole on the end, preventing blood return even though it was in the artery (ultrasound guided and palpation).Upon removing the needle, the physician attempted to flush it but was unable to.The wire was attempted to be passed through the needle unsuccessfully.As a result, an additional stick had to be completed on the patient and a new kit was used.No adverse effects to the patient have been reported.
Event or Problem Description
No additional information regarding patient and/or event details has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unchanged or unavailable.Investigation ¿ evaluation.It was reported by hennepin county medical center that the needle in a single lumen pressure monitoring set (rpn: c-pms-250, lot: 9514102) was obstructed.During an arterial catheter placement, the physician used palpation and ultrasound to guide the needle into the artery; however, there was no blood return, so the needle was removed.The user attempted to flush and advance a wire guide through the needle but was unsuccessful.As a result, a new device was obtained, and an additional puncture was made to complete the procedure.As reported, the patient did not experience any adverse effects or require any additional procedures due to this occurrence.Reviews of the documentation including the complaint history, device history record, drawing, instructions for use (ifu), quality control procedures and specifications, as well as a visual inspection, functional test, and dimensional analysis of the returned device, were conducted during the investigation.One used device was received in a relatively undamaged condition.A test wire guide was initially unable to be advanced through the needle lumen.Similarly, the needle could not be flushed with water.Eventually, the wire guide was able to be advanced through the needle after unknown matter was pushed out of the lumen.Dimensional analysis confirmed that the inner and outer diameter of the needle were manufactured to the correct specifications.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded sufficient controls are in place to detect this failure mode prior to release.A review of the device history record (dhr) for lot 9514102 and relevant needle subassembly lots ic9416380 and ic9431203 found no nonconformances that could have contributed to the reported failure mode.It should be noted that the no other complaints were associated with final product lot number.A supplier corrective action request was previously initiated for this issue, and the supplier concluded that the issue was related to a manufacturing process.The supplier has implemented corrective actions since this lot was manufactured.Cook also reviewed product labeling.Instructions for use (ifu) document c_t_ulmbhce_rev6 [uncoated and heparin-coated central venous catheters] is packaged with this device.The product ifu states the following in consideration of the reported failure mode: how supplied upon removal from package, inspect the product to ensure no damage has occurred.The information provided upon review of the dmr, ifu, dhr, and returned device suggests that the device was manufactured out of specification.Additional nonconforming devices in the field were suspected, so a recall was performed on the affected lots.Based on the information provided, examination of the returned product and the results of our investigation, it was concluded that a supplier-related manufacturing issue contributed to the event.The supplier of the needle opened a capa regarding this failure and attributed the failure to a gap in the manufacturing process.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.

• Brand Name: SINGLE LUMEN PRESSURE MONITORING SET
• Common Device Name: DQY CATHETER, PERCUTANEOUS
• 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: 11915293
• Report Number: 1820334-2021-01436
• Device Sequence Number: 19741183
• Product Code: DQY
• UDI-Device Identifier: 00827002028388
• UDI-Public: (01)00827002028388(17)220211(10)9514102
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/12/2022

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: 02/11/2022
• Device Model Number: N/A
• Device Catalogue Number: C-PMS-250
• Device Lot Number: 9514102
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/24/2021
• Supplement Date Received by Manufacturer: 06/15/2022
• Initial Report FDA Received Date: 06/01/2021
• Supplement Report FDA Received Date: 07/12/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/11/2019
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown