MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. MASTOID PACK; KIT, SURGICAL INSTRUMENT, DISPOSABLE

Catalog Number 89-7083

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

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/01/2015

Event Type  malfunction  

Manufacturer Narrative

Investigation findings: the work order was reviewed for discrepancies that could contribute to the reported issue.There were no discrepancies identified.Raw material (b)(4), connector female ll, lot number 432282764x was utilized within the finished good.The raw material is supplied to deroyal by (b)(4).The 2013-2015 scar/snl logs were reviewed for similar complaints.A similar complaint was identified in 2014.The complaint was filed by the same reporting customer.(b)(4) was issued due to this report.An additional follow-up was performed on 05/12/2015 to alert the vendor of the sample availability.The sample was shipped to the vendor for evaluation.On 05/26/2015, the qc complaint specialist followed up with the vendor via phone in reference to the outstanding scar response.It was stated that the samples have been received and currently are at the plant for investigation.Additional time will be required.The component evaluation form that was evaluated as part of the complaint investigation has identified that the product is supplied deroyal sterile but is indicated that the product can be resterilized a second time with ethylene oxide.Ethylene oxide is the same method of sterilization utilized by deroyal to sterilize the trays.Investigation is incomplete at this time.A follow-up report will be filed when new information is available.

Event Description

The female luer adapter in all of the mastoid and acoustic packs continues to leak.This complaint has been submitted before; yet, we continue to experience this issue with every pack.We use the (b)(4) argyle adapter (8888275008) that we stock separately and have no leak issues with it.It was my understanding that this is the item that is supposed to be in the pack.If it is, perhaps something is happening to it during resterilization.How can this be resolved?.

Manufacturer Narrative

Root cause: the female luer adapter contained within the finished good kit is supplied to deroyal by covidien.Therefore, a supplier corrective action request (scar) was submitted to covidien.In its response, covidien stated the device history record (dhr) was reviewed and indicated that product was released meeting all quality standard requirements.There were no non-conforming issues reported during the manufacturing of this product.Three samples were received for evaluation.After a visual and functional inspection, the issue reported could not be confirmed via visual and functional inspection.There were no leaks present in the connector.Corrective action: a corrective action has not been taken.Investigation summary: an internal complaint ((b)(4)) was received indicating that a female luer adapter (raw material 908449, lot number 432282764x) contained within a mastoid pack (finished good 89-7083, lot number 38573066) was leaking.The adapter contained within the finished good kit is supplied to deroyal by covidien.Therefore, a scar was submitted to covidien.The returned sample also was forwarded to covidien for evaluation.The 2013-2015 scar and supplier notification letter logs were reviewed for similar complaints.One similar complaint was identified in 2014 and was filed by the same reporting customer.The work order for the reported finished good lot number was reviewed for discrepancies that could contribute to the reported issue.No discrepancies were identified.The component evaluation form for the adapter was evaluated.It was confirmed that the product is supplied to deroyal sterile, but the supplier has indicated the product can be sterilized a second time with ethylene oxide.Ethylene oxide is the method of sterilization that deroyal utilizes to sterilize convenience kits.Preventive action: a preventive action has not been taken.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

The female luer adapter in all of the mastoid and acoustic packs continues to leak.This complaint has been submitted before; yet, we continue to experience this issue with every pack.We use the covidien argyle adapter (8888275008) that we stock separately and have no leak issues with it.It was my understanding that this is the item that is supposed to be in the pack.If it is, perhaps something is happening to it during resterilization.How can this be resolved?.

• Brand Name: MASTOID PACK
• Type of Device: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 4810848
• MDR Text Key: 22393696
• Report Number: 3005011024-2015-00002
• 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,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/28/2015,08/15/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-7083
• Device Lot Number: 38573066
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/11/2015
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/01/2015
• Event Location: Hospital
• Date Manufacturer Received: 05/01/2015
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/01/2015
• 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