MAUDE Adverse Event Report: COOK INC COOK CERVICAL RIPENING BALLOON W/STYLET; PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA

Model Number	N/A
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or 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 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 or Problem Description
As reported, a "white hair" was found on a cook cervical ripening balloon w/stylet.The device did not make patient contact.Another device was used to complete the procedure.No adverse effect to the patient was reported.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown, unavailable, or unchanged.Correction h6: annex g.Event description: as reported, a "white hair" was found on a cook cervical ripening balloon w/stylet.The device did not make patient contact.Another device was used to complete the procedure.No adverse effect to the patient was reported.Investigation evaluation: reviews of the documentation, including the complaint history, device history record, instructions for use (ifu) and quality control procedures, as well as a visual inspection of the returned device, were conducted during the investigation.The complaint device was returned for evaluation in opened packaging.Biomatter and hair can be seen at the distal tip on both balloons.Additionally, a document-based investigation evaluation was performed.A review of the device master record (dmr) concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.A review of the dhr for the complaint device lot records no relevant non-conformances.A database search for complaints on the reported lot found no additional complaints reported from the field.Cook concluded that no nonconforming product from this lot exists in house or in the field.The device is provided with instructions for use which state, "upon removal from the package, inspect the product to ensure no damage has occurred." based on the information provided and inspection of the returned device, cook confirmed that foreign matter was inside the packaging.Cook concluded that a manufacturing event contributed to this incident as well as a quality control deficiency.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: COOK CERVICAL RIPENING BALLOON W/STYLET
• Common Device Name: PFJ, DILATOR, CERVICAL, HYGROSCOPIC-IAMINARIA
• 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: 15908271
• Report Number: 1820334-2022-01805
• Device Sequence Number: 17650884
• Product Code: PFJ
• UDI-Device Identifier: 00827002198913
• UDI-Public: (01)00827002198913(17)240315(10)13823533
• Combination Product (Y/N): N
• PMA/510(K) Number: K131206
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility,Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/01/2023

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: 03/15/2024
• Device Model Number: N/A
• Device Catalogue Number: J-CRBS-184000
• Device Lot Number: 13823533
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/29/2022
• Supplement Date Received by Manufacturer: 01/11/2023
• Initial Report FDA Received Date: 12/02/2022
• Supplement Report FDA Received Date: 02/01/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 03/15/2021
• 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