MAUDE Adverse Event Report: DEROYAL INDUSTRIES MANIFOLD KIT; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 77-400990

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/13/2015

Event Type  malfunction  

Event Description

The control syringe is leaking during an angiogram procedure.

Manufacturer Narrative

Investigation findings: the qfi report was reviewed for sales and similar complaint information.Deroyal has sold (b)(4) cases of the finished good from 2013 to 2015.There have been no reports rec'd for the finished good identified.Raw material sy-1031 was identified as the syringe referenced within the complaint.The raw material is supplied to deroyal by (b)(4).(b)(4) has sold (b)(4) each of the finished good from 2013 to 2015.There were no records of the reported issue identified during the review of files at (b)(4).As part of the investigation, additional information was requested via email on 04/21/2015 from the deroyal sales representative.Refer to the below information requested: " can you follow-up with the customer and confirm if the lot number will be unavailable for the report? the sample has been identified as not being available.Did the customer discard the sample? within the quantity details, you have listed 25 cases.Can you provide information as to how many times the actual issue occured? the text also indicates the issue occurred after use (when did the quality issue occur? after use) but then states, 'the control syringe is leaking during an angiogram procedure.' can you please clarify when the issue was occuring and the reported issue observed? the text indicates the failure resulted in a delay in the medical procedure.Can you please identify the length of the delay." the sales representative responded on 04/30/2015.The response will be retained with the qc complaint specialist email file.Within the response, it is stated that, "no additional information is available from the reporting customer and there were 1-2 syringes that (were) leaking during the procedure (over the last year), but they were discarded.He did not have a lot number to reference." the reporting customer was quoted as stating, "as far as the leaky syringe, no worries no one was hurt." due to the reported lot number not being available, representative dhr records were reviewed for the raw material identified.Work order/dhr (b)(4) were evaluated and no discrepancies were identified during the molding process.Upon the release of the lot from (b)(4), the product was provided to the deroyal (b)(4) for assembly.The work order is created as part of the (b)(4) manufacturing process and returned with the product to (b)(4).In addition, the work order was evaluated and found to contain final inspection documentation completed by (b)(4).Refer to the final testing for qfi (b)(4) attachment for evidence from the three lots.The entire tested product was found to be acceptable and the lot released for commercial distribution.Correction: a correction has not been taken.Root cause analysis: the true root cause for the reported issue is unable to be determined due to lack of information and physical sample for eval.Corrective action and/or systemic correction action taken: a corrective action has not been taken for the complaint due to the investigation and root cause determination.Preventive action: a preventive action has not been taken for the complaint due to the investigation and root cause determination.Investigation is complete at this time.This report will be updated if more information becomes available.

• Brand Name: MANIFOLD KIT
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES; 700 martin luther king, jr.; sanford FL 32771
• Manufacturer Contact: 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4774434
• MDR Text Key: 5796764
• Report Number: 1033554-2015-00015
• Device Sequence Number: 1
• Product Code: KDD
• 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: User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/12/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/14/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 77-400990
• Device Lot Number: NP
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 04/13/2015
• Event Location: Hospital
• Date Manufacturer Received: 04/13/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1