MAUDE Adverse Event Report: COOK INC WAYNE PNEUMOTHORAX SET; JOL CATHETER AND TIP, SUCTION

Model Number	N/A
Medical Device Problem Codes	Fracture (1260); Material Separation (1562)
Health Effect - Clinical Code	No Code Available (3191)
Date of Event	07/04/2019
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
(b)(6).Pma/510(k) #: exempt.(b)(4).A follow up report will be submitted should additional relevant information become available.
Event or Problem Description
It was reported that on (b)(6) 2019, at the (b)(6) hospital, a wayne pneumothorax set external drain connection broke apart from the device's three-way attachment after a pleural catheter insertion.The patient was a (b)(6) year old female who had a pre-existing right hepatic hydrothorax.The external connection point between the drain and the three-way attachment located on the catheter separated.Conditions as to which this event occurred were reported as uncertain.The physician was required to establish a connection in place and did so successfully, allowing the drain to function as intended.The internal portion of the catheter remained in-tact without issue.The drain was removed on (b)(6) 2019, "likely due to the fact that the effusion had largely resolved at that point, and since there was some concern as to the integrity of the drain at that point, the decision was made to remove the drain," as stated by the physician.Another device was placed on (b)(6) 2019 due to re-accumulation of the pleural effusion.Regarding the re-insertion, the physician also stated that, "there is an argument to be made that the reinsertion is not directly a result of the breakage in the initial drain." as reported, the patient did not experience any adverse effects due to this occurrence.
Additional Manufacturer Narrative
Device code: 1260 [fracture] - device code was changed after the investigation additional information: method code: testing of device from same lot/batch returned from user.Investigation ¿ evaluation.A review of the documentation including the device history record, instructions for use (ifu), manufacturing instructions and quality control, as well as a visual inspection and functional test of the returned device was conducted during the investigation.Only the hub of one open wayne pneumothorax set was returned.Eleven unopened wayne pneumothorax sets were returned.A visual exam and a functional test to check the security of the hub were performed on the unopened devices.It was noted that one of the hubs came off during the functional test, and that the flare is slightly crooked and didn't sit well in the cap.The flare is uneven.Additionally, a document based investigation evaluation was performed.A review of the device master record found that sufficient inspection activities are in place to identify this failure mode prior to distribution.The device aspect in question was visually and functionally inspected by quality control and no related gaps in production or processing controls were noted.A review of the device history record found no relevant nonconformances related to this incident.A database search revealed this complaint to be 1 of 2 associated with the reported complaint lot number.As there are no related non-conformances, adequate inspection activities have been established, and there was evidence that the dhr was fully executed, there is no evidence to suggest there is any nonconforming product in house or out in the field.A review of the product labeling for the device was completed.The instructions for use state the following instructions related to the reported failure mode: instructions for use 12.The catheter and connected drain lines should be secured to the patient.Excessive tension on the catheter connections (e.G., in instances of patient movement where the catheter is connected to a vacuum or drainage collection apparatus) may cause catheter/hub separation or accidental catheter dislodgement.To help prevent this from occurring, it is recommended to do one or both of the following: a.Secure the catheter hub to the patient's skin by placing tape, suture, or a catheter securement device at the location shown in the illustration below.B.Form a strain relief loop in the connecting tube, as shown in the illustration below, and secure the loop to the patient's skin with tape, suture, or catheter securement device.Based on the information provided, inspection of the returned product, and the results of the investigation, a definitive cause was not established.As it was reported the devices may have been secured to the bed at the time of the incident, it s possible the failure may be related to issues with securement of the device.Per the product's ifu - to alleviate the excessive tension on the catheter connections, it is recommended to use catheter securement device and form a strain relief loop to avoid catheter/hub separation or accidental catheter dislodgement.It is also possible that the failure could be due to a manufacturing issue.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
On 07nov2019, it was reported by a doctor who worked at the complainant facility and was aware of the separation issues with the complaint product, that the drainage tubing of the in-situ chest tubes were attached to the hospital bed at the time of the incident.

• Brand Name: WAYNE PNEUMOTHORAX SET
• Common Device Name: JOL CATHETER AND TIP, SUCTION
• Manufacturer (Section D): COOK INC; 750 daniels way; bloomington IN 47404
• MDR Report Key: 8861786
• Report Number: 1820334-2019-01937
• Device Sequence Number: 11247257
• Product Code: JOL
• UDI-Device Identifier: 00827002111820
• UDI-Public: (01)00827002111820(17)210323(10)9709128
• Combination Product (Y/N): N
• Initial Reporter Country: SG
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• Device Explanted Year: 2019
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/05/2019

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: 03/23/2021
• Device Model Number: N/A
• Device Catalogue Number: C-UTPT-1400-WAYNE-112497
• Device Lot Number: 9709128
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/30/2019
• Initial Date Received by Manufacturer: 07/19/2019
• Supplement Date Received by Manufacturer: 11/07/2019
• Initial Report FDA Received Date: 08/05/2019
• Supplement Report FDA Received Date: 12/05/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 80 YR
• Patient Weight: 50