MAUDE Adverse Event Report: DAVOL SURGICAL INNOVATIONS -9616067 RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE

Catalog Number 0070800

Device Problems Aspiration Issue (2883); Detachment of Device or Device Component (2907)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/30/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the drain was placed on the patient in the operating room.Two or three hours after the operation, in the intensive care unit, the nurse realized there was no aspiration available.The welding part was found detached from the y-connector.It was replaced with another bottle with a y-connector.No health hazards including hematomas were observed.

Manufacturer Narrative

Received 1 used y-connector with only the drainage tubing still attached.The reported event was confirmed as a manufacturing related issue.A visual inspection noted that the weld on the y-connector had detached.The y part of the connector was not returned for evaluation.The visual inspection showed defective sealing at the junction of both parts (tailpiece / "y¿ connector head), due to a poor welding during the bard (b)(4) manufacturing process.A functional test was not performed due to the sample's condition.A dimensional inspection was not performed due to the sample's condition.The lot number is unknown therefore the device history record could not be reviewed.The labeling review results state the following: "action was taken by division bmd.The activity was initiated by ¿evaluate and provide update on documentation of servicing for y-connector detachments complaints,¿ based on the current ifu, bmd suggested and update on the ifu to reflect ¿statement ¿do not squeeze the ¿-connector¿.The revised instructions for use state the following:"* do not squeeze the y connector.There is a risk of break of y connector." (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.

Event Description

It was reported that the drain was placed on the patient in the operating room.Approximately 2-3 hours after the operation, while the patient was in the intensive care unit, the nurse realized that there was no aspiration available.The welded portion of the device was found detached from the y-connector.As a result, the device was replaced with another bottle with a y-connector.No health hazards including hematomas were observed.

• Brand Name: RELIAVAC 400 EVACUATOR, 400ML CAPACITY, Y-CONNECTING TUBE
• Type of Device: EVACUATOR
• Manufacturer (Section D): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer (Section G): DAVOL SURGICAL INNOVATIONS -9616067; ave. roberto fierro #6408; parque industrial aeropuerto; cd. juarez, chih s.a. de c.v. 32690 ; MX 32690
• Manufacturer Contact: janna parks ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 5803898
• MDR Text Key: 50644434
• Report Number: 1018233-2016-00922
• Device Sequence Number: 1
• Product Code: GCY
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 07/18/2016

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
• Device Operator: Health Professional
• Device Catalogue Number: 0070800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/06/2016
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 06/24/2016
• Initial Date FDA Received: 07/19/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/14/2016
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention