MAUDE Adverse Event Report: DEROYAL INDUSTRIES, INC. OPHTHALMOLOGY PACK; GENERAL SURGERY TRAY (KIT)

Catalog Number 89-6263

Device Problem Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 06/15/2016

Event Type  malfunction  

Manufacturer Narrative

Investigation summary an internal complaint ((b)(4)) was received indicating that blue towel contained within an ophthalmology pack ((b)(4)) was linting, causing the surgical staff to reinspect hands after touching the towel.The raw material is supplied to deroyal by (b)(4).A supplier corrective action request (scar) was issued june 22, 2016, to (b)(4) and is due august 4, 2016.A response has not been received at this time.The investigation is ongoing at this time.If new and critical information is received, this report will be updated.

Event Description

Lint on the blue towels is coming off on the surgical staff's hands, which is an issue when dealing with the eyes.It causes the staff to have to reinspect their hands to check for lint before returning to the procedure.The incident occurred during use in an ophthalmic procedure.

Manufacturer Narrative

Root cause: the towel in the finished good kit is supplied to deroyal by us (b)(4).As such, a supplier corrective action request (scar) was submitted to us (b)(4).In its response, the supplier indicated that the failure could not be confirmed.Representative samples were submitted to a third-party laboratory for evaluation.Results of the evaluation failed to detect lint on the samples submitted.Corrective action: in its scar responds, us (b)(4) stated a corrective action has not been taken.Testing of the representative samples failed to duplicate the reported issue.Investigation summary an internal complaint (call (b)(4)) was received indicating that blue towel contained within an ophthalmology pack (finished good (b)(4), lot number 41735601) was linting, causing the surgical staff to reinspect hands after touching the towel.As part of the us (b)(4) investigation, representative samples were submitted for a third-party lab evaluation.Three lots were inspected, and no traces of lint were present.Additionally, no visible lint was present on retention samples during the folding and delinting process verification.The work order for the finished good was reviewed for discrepancies that would have contributed to the reported event.None were identified.The blue or towel contained within the finished good is raw material (b)(4), which is supplied to deroyal by (b)(4).A two-year review of the scar and supplier notification letter (snl) logs confirmed that similar complaints have been reported for this issue.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

Lint on the blue towels is coming off on the surgical staff's hands, which is an issue when dealing with the eyes.It causes the staff to have to reinspect their hands to check for lint before returning to the procedure.The incident occurred during use in an ophthalmic procedure.

• Brand Name: OPHTHALMOLOGY PACK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• Manufacturer (Section G): DEROYAL INDUSTRIES, INC.; 1501 east central avneue; lafollette TN 37766
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 5797961
• MDR Text Key: 49640530
• Report Number: 3005011024-2016-00017
• Device Sequence Number: 1
• Product Code: LRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K842648
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Reporter Occupation: Nurse
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 09/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/15/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 89-6263
• Device Lot Number: 41735601
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/16/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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