MAUDE Adverse Event Report: DEROYAL INTERCONTINENTAL, S.R.L. STOPCOCK 3 WAY OFF MLL 1P OP; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Model Number 15-1L36

Device Problems Fluid/Blood Leak (1250); Leak/Splash (1354); Mechanical Problem (1384)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/25/2017

Event Type  malfunction  

Manufacturer Narrative

Root cause: a root cause is unable to be determined at this time.Corrective action: due to the root cause determination, a corrective has not been determined.The lot in question was on reduced sample level testing.Current lots are on tightened sample level testing.Investigation findings: an internal complaint (b)(4) was received indicating that a stopcock leaked during a procedure.Samples were returned for evaluation and four of these samples were tested.The following tests were conducted: torque test, vacuum leak testing, and hydrostatic leak testing.During hydrostatic testing, leakage from the bottom of the handle was observed in two samples.The handles were removed from the bodies and inspected for anything that may cause leakage.Nothing was identified.Handles from the same raw material lot were inserted onto the body previously tested and both samples passed.In one of the samples that leaked, green-colored water was used to see where the leak originated.There was no distinct evidence as to where the leak originated.The device history record was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.There have been no changes to the material used in production of this product.Year to date (b)(4) eaches have been sold.This is the first reported issue of this nature.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

It was reported that during the procedure, when attempting to pressurize, the indeflator will not hold the pressure.It was noted that there was contrast leaking from the stopcock.The stopcock was exchanged for a new one and there was no leak noted.The procedure was successfully completed.There was no clinically significant delay in procedure and no adverse patient effects.

• Brand Name: STOPCOCK 3 WAY OFF MLL 1P OP
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DEROYAL INTERCONTINENTAL, S.R.L.; km 7 autopista joaquin balague; pizano free zone building 49; santiago, santiago ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km 7 autopista joaquin balague; pisano free zone building 49; santiagio, santiago ; DR
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 6818671
• MDR Text Key: 83652147
• Report Number: 3004605321-2017-00003
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 08/24/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/24/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15-1L36
• Device Lot Number: 44104590
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/02/2017
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 07/25/2017
• 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