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

Catalog Number	C-PPDJ-500-WOOD-IMH
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	07/09/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Weight; actual weight reported as (b)(6) kg.(b)(6).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 the needle broke after 1.5 cm insertion into the catheter when utilizing the wood pleural/pneumopericardial drainage set outside of the patient for thorax drainage procedure for air in the right side of the lung.An alternate manufacturer's product was utilized to complete the procedure.According to the initial reporter, the patient did not experience any adverse effects due to this occurrence.
Event or Problem Description
Additional information provided on 24sep2018 by the customer: the needle broke during placement and was noticed upon catheter removal.The catheter was removed because the customer was unable to access site and could not position drainage.
Additional Manufacturer Narrative
Investigation - evaluation a review of the complaint history, drawings, dimensional verification, device history record, documentation, instructions for use (ifu), manufacturing instructions, specifications, trends, quality control, and visual inspection of the returned device was conducted during the investigation.The customer returned one used and four unused device sets for evaluation.Visual inspection of the used set verified the needle was fractured approximately 1.5cm from the distal tip.Surface damage was not noted on the catheter.The unused devices were inspected visually and used in destructive testing in an attempt to replicate the reported failure.A document-based investigation was performed.There is no evidence to suggest the finished product was not made to specifications.A review of the device history record of the finished product shows one related nonconformance, however, this device was scrapped at quality control.A complaint history search revealed that there were no other reported complaints for this lot number.Based on the information provided, examination of the returned product, and the results of our investigation, a definite root cause could not be determined.Per the [quality engineering] risk assessment, no further action is required.Monitoring will continue to be performed 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: WOOD PLEURAL/PNEUMOPERICARDIAL DRAINAGE SET
• Common Device Name: GBX CATHETER, IRRIGATION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 7760580
• Report Number: 1820334-2018-02225
• Device Sequence Number: 11077291
• Product Code: GBX
• UDI-Device Identifier: 00827002557185
• UDI-Public: (01)00827002557185(17)210510(10)8634061
• Combination Product (Y/N): N
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/23/2018

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: 05/10/2021
• Device Catalogue Number: C-PPDJ-500-WOOD-IMH
• Device Lot Number: 8634061
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/31/2018
• Initial Date Received by Manufacturer: 07/11/2018
• Supplement Date Received by Manufacturer: 09/24/2018
• Initial Report FDA Received Date: 08/07/2018
• Supplement Report FDA Received Date: 10/23/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 1 DA
• Patient Weight: 3