MAUDE Adverse Event Report: COOK INC FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET; GBX CATHETER, IRRIGATION

Model Number	G55723
Medical Device Problem Code	Device Contaminated During Manufacture or Shipping (2969)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	02/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Pma/510(k): 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
It was reported that there was a piece of hair observed inside the sealed packaging of a fuhrman pleural/pneumopericardial drainage set.Consequently, the device was not used.
Additional Manufacturer Narrative
Blank fields on this form indicate the information is unknown or unavailable.Additional information: b3, b5, d9.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.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.
Event or Problem Description
No procedure/planned procedure occurred.The hair was noticed in the packaging as it was visually inspected before being stored for use.
Additional Manufacturer Narrative
Investigation ¿ evaluation an issue was reported with a fuhrman pleural/pneumopericardial drainage set ((b)(6)) from lot 13213406.An unknown fiber was observed inside the sealed packaging.Cook became aware of this event upon being notified by loma linda mercantile.The failure was noted before putting it on the shelf, so there was no patient involvement.Reviews of the complaint history, device history record, instructions for use (ifu), and quality control procedures, as well as a visual inspection of the returned product, were conducted during the investigation.The complaint device was returned sealed in its original packaging.A dark fiber is visible within in the pouch.Additionally, a document based investigation evaluation was performed.Review of the device master record has shown that sufficient controls are in place to detect this failure mode prior to release.The risks of this device are acceptable when weighed against the benefits.The device is shipped with instruction for use (ifu) which provides the following information to the user related to the reported failure mode: "how supplied supplied sterilized by ethylene oxide gas in peel-open packages¿.Sterile if package is unopened or undamaged.Do not use the product if there is doubt as to whether the product is sterile." a review of the device history record (dhr) was also condcted as a part of the investigation to check for failure-related nonconformances and additional complaints.The dhr for the complaint lot showed no nonconformances.A database search revealed no other complaints under this lot number at the time of this investigation.Since there are no related nonconformances or other complaints from this lot, there is no evidence that additional nonconforming product exists in house or in the field.Based on the information provided, confirmation of a fiber within the sealed packaging, and the results of the investigation, it was concluded that the main cause of failure is manufacturing-related.The appropriate personnel have been notified.Per the quality engineering risk assessment no further action is required.Cook 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.
Event or Problem Description
No additional information regarding the patient and/or event has been received since the previous medwatch report was sent.

• Brand Name: FUHRMAN PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 11379625
• Report Number: 1820334-2021-00390
• Device Sequence Number: 3712481
• Product Code: GBX
• UDI-Device Identifier: 00827002557239
• UDI-Public: (01)00827002557239(17)230527(10)13213406
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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: company representative,health
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/14/2021

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: No Information
• Device Expiration Date: 05/27/2023
• Device Model Number: G55723
• Device Catalogue Number: C-PPD-850-IMH
• Device Lot Number: 13213406
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/09/2021
• Initial Date Received by Manufacturer: 02/18/2021
• Supplement Date Received by Manufacturer: 03/10/2021; 05/06/2021
• Initial Report FDA Received Date: 02/25/2021
• Supplement Report FDA Received Date: 03/15/2021; 05/14/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1