MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. HIGH PRESSURE LINE, 72 INCH; ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS

Catalog Number 301225A

Device Problems Infusion or Flow Problem (2964); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/28/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: call 34252 was received indicating that finished good 301225a, line hp 72 inch f-r/a, "failed at rotating adaptor end." as a result of the failure, "fluid went over the staff." when the report was received, it was determined that a joint investigation with critical disposables would be required.The samples were received and forwarded to a critical disposables representative for evaluation.The actual lot number in which the issue occurred was not identified, but potential lot numbers were identified within the complaint text.Work order/ dhr raw material/ finished good # 36567308 and lot # 36715614 were evaluated and no discrepancies were identified during the molding process.Upon release of the lot from cdi (bp 50), the product was provided to the dominican republic manufacturing plant (bp 65) for assembly.The work order is created as part of the dominican republic manufacturing process and dominican republic completes final inspection (cdi.Ms.004).The two potential lots reported 10,400 pieces and were produced in july 2014.The qc complaint specialist reviewed the qfi report for sales and similar complaint information.Deroyal has sold 83,537 cases/33,414,800 each of finished good 301225a from 2013 to present.No similar complaints were identified during the review period.Deroyal will continue to monitor trends for this failure and will recognize in the future if it transitions into a recurring issue.Correction: because the reported potential lots were not found in inventory at cdi, no correction action was taken.Root cause analysis: the reported issue was determined to be an isolated report for the finished good.Upon initial evaluation of the sample, the true root cause has not been determined.However, if further evaluation of the sample reveals an exact cause, the report will be reopened.Corrective action and/or systemic correction action taken: the product number reported has been placed on tightened inspection for final testing per corp.Prc.060 application of ansi / asq z1.4.Preventive action: due to the investigation and root cause determination, a preventive action has not been taken.The investigation is complete at this time.The report will be updated if more information becomes available.

Event Description

It was reported that the high pressure line failed at rotating adaptor end.Fluid went over staff, was well below maximum pressure (1000psi) when in use.

• Brand Name: HIGH PRESSURE LINE, 72 INCH
• Type of Device: ADAPTOR, STOPCOCK, MANIFOLD, FITTING, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; km 7 autopista joaquin balague; pisano free zone building 49; santiago ; DR
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; km 7 autopista joaquin balague; pisano free zone building 49; santiago ; DR
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, tn ; 3626112
• MDR Report Key: 5136769
• MDR Text Key: 216919618
• Report Number: 3004605321-2015-00016
• Device Sequence Number: 1
• Product Code: DTL
• Combination Product (y/n): N
• Reporter Country Code: MY
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 09/25/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 301225A
• Device Lot Number: NOT PROVIDED
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/14/2015
• Date Manufacturer Received: 08/28/2015
• 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