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

Catalog Number	C-PPD-850
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	05/22/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Occupation unknown.Two additional x-rays were required.Pma/510k: 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 eight days after the insertion of a fuhrman pleural/pneumopericardial drainage set, (rpn:c-ppd-850) there was still bubbling in the drainage system.The patient was a preterm baby born at (b)(6) gestation.The patient required high frequency oscillating ventilation on day one of life.Patient was given three doses of bovine lavage extract surfactant (bles) during the first 24 hours of life.At 24 hours of life, patient required a needle aspiration of air from a pneumothorax.The pneumothorax progressed over the next few days while the patient was on high frequency jet ventilation.The continuing progress of the pneumothorax required bilateral insertion of fuhrman pleural pneumopericardial tubes.The device was effective in removing air from the pneumothorax.However, after eight days of insertion there was "still bubbling occurring" in the drainage system despite x-rays showing the pneumothorax was resolved.Upon further investigation by the customer it was determined that when the product was occluded close to the patient there continued to be air leakage in the drainage system.The customer reported that the leakage of air appears to be at the "connection point of the translucent hard plastic parts of the distal end of the drainage set." the customer reported confirming this finding when it was still possible to pull air up the syringe when it was attached to the distal end and the drainage tube was clamped.
Additional Manufacturer Narrative
Investigation/evaluation: a review of documentation including the complaint history, device history record, drawing, instructions for use (ifu), manufacturing instructions, quality control and specifications of the device was conducted during the investigation.The complaint device was not returned; therefore, no physical examinations could be completed.However, a document-based investigation evaluation was performed.It was concluded that sufficient inspection activities are in place to identify this failure mode prior to distribution.The risks associated with these devices are acceptable when weighed against the benefits.All tested devices met the acceptance criterion for liquid leakage, air aspiration and tensile forces at their specific break acceptance criteria.A review of the device history record for lot 9355682 found no nonconformances that could have contributed to the failure mode.It should be noted that there were no other complaints reported for this lot number.There is no evidence to suggest that nonconforming product exists in house or in the field.The instructions for use (ifu), provides the following information to the user related to the reported failure mode: "instructions for use: verify placement into the pleural or pericardial space by aspiration of air or fluid into syringe.Remove syringe once placement is verified.Advance the catheter into position.Remove the wire guide and attach the multipurpose adapter to the catheter.How supplied: upon removal from package, inspect to ensure no damage has occurred." based on the information provided, no returned product and the results of our investigation, a definitive root cause could not be established.The appropriate personnel have been notified.Per the quality engineering 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.
Event or Problem Description
A clarification of the location of the leakage was provided on (b)(6) 2019.It was originally reported that the leak occurred at the "connection point of the translucent hard plastic parts of the distal end of the drainage set," which the area representative confirmed to be the hub/manifold of the tube.

• 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: 8745685
• Report Number: 1820334-2019-01578
• Device Sequence Number: 19466547
• Product Code: GBX
• UDI-Device Identifier: 00827002039742
• UDI-Public: (01)00827002039742(17)211205(10)9355682
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: consumer
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 08/14/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 12/05/2021
• Device Catalogue Number: C-PPD-850
• Device Lot Number: 9355682
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/08/2019
• Supplement Date Received by Manufacturer: 07/18/2019
• Initial Report FDA Received Date: 06/28/2019
• Supplement Report FDA Received Date: 08/14/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PLEUR-EVAC® CHEST DRAINAGE SYSTEM; PLEUR-EVAC® CHEST DRAINAGE SYSTEM
• Outcome Attributed to Adverse Event: Other
• Patient Age: 8 DA