MAUDE Adverse Event Report: COOK INC ULTRAXX NEPHROSTOMY BALLOON AND SET; LJE CATHETER, NEPHROSTOMY

Model Number N/A

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 04/16/2021

Event Type  malfunction  

Manufacturer Narrative

A follow up report will be submitted should additional relevant information become available.

Event Description

As reported, prior to a percutaneous nephrolithotomy, an ultraxx nephrostomy balloon and set was opened and a hair was found in the packaging.Another of the same device was used to complete the procedure.The device did not make patient contact.No adverse effects to the patient were reported.

Event Description

No new patient or event information since the last report was submitted.

Manufacturer Narrative

Blank fields on this form indicate the information is unknown, unchanged, or unavailable.Event summary cook was informed of an incident involving a ultraxx nephrostomy balloon and set.It was reported that a hair was observed inside the packaging.Another device was used to complete the procedure.The patient reportedly experienced no harm as a result of the issue.Investigation ¿ evaluation a visual inspection of the returned device was conducted.A document-based investigation was also performed including a review of complaint history, device history record, the instructions for use, manufacturing instructions, and quality control data.The complainant returned one ultraxx nephrostomy balloon and set.Visual exam notes a brown fiber inside shipping tray and caught in side seal.A review of the device history record (dhr) 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 related complaints from the lot 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.Pouches are inspected for gross defects, including hair, when sealing and at the subsequent quality inspection process.Cook has concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The returned device was found to have a hair that had been sealed between the tray and tyvek lid.The cause was determined to be a manufacturing issue from the hair not being detected during sealing, and a quality issue that the hair was not detected during the quality inspection.Retraining of the appropriate manufacturing procedure was conducted for the packaging operator.The quality inspector was on extended leave from cook with the return date unknown.When the inspector returns, retraining will be conducted.Per the quality engineering risk assessment, no further action is warranted.Cook medical 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: ULTRAXX NEPHROSTOMY BALLOON AND SET
• Type of Device: LJE CATHETER, NEPHROSTOMY
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11777714
• MDR Text Key: 250425954
• Report Number: 1820334-2021-01292
• Device Sequence Number: 1
• Product Code: LJE
• UDI-Device Identifier: 00827002303577
• UDI-Public: (01)00827002303577(17)231103(10)13530662
• Combination Product (y/n): N
• PMA/PMN Number: K024050
• 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: 06/25/2021

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: No Information
• Device Expiration Date: 11/03/2023
• Device Model Number: N/A
• Device Catalogue Number: UNBS-10-15-CS
• Device Lot Number: 13530662
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2021
• Initial Date Manufacturer Received: 04/16/2021
• Initial Date FDA Received: 05/05/2021
• Supplement Dates Manufacturer Received: 06/17/2021
• Supplement Dates FDA Received: 06/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1