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

Model Number	89-9205
Medical Device Problem Code	Contamination /Decontamination Problem (2895)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/07/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation summary: an internal complaint (b)(4) was received for a c-section pack (part 89-9205, lot 49830232) that contained a lap sponge that was discovered to contain a hair.This was noticed after the patient had already received her spinal for the procedure.The room had to be torn down and reset, resulting in a delay in the procedure.The defective sample was not available for return.The work order was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials was reviewed and the affected component was identified as raw material 832894, which is supplied to deroyal by covidien.The raw material sponges come to deroyal in a bundled pack of 5.These packs are not opened during the kit assembly process.Due to the reported location of the hair and the fact that the sponge packs are not unbundled by deroyal, it was determined that the hair contamination source was not the kit assembly process.Due to the nature of the reported incident, a supplier corrective action request was issued to covidien.As of the date of this report, a response has not been received.The investigation is ongoing at this time.If and when new information is received, this report will be updated.
Event or Problem Description
A hair was found on a lap sponge contained in a c-section pack.The room had to be torn down and reset, creating a delay in the procedure.This occurred after the patient had already received her spinal.
Additional Manufacturer Narrative
Root cause: the root cause could not be determined by deroyal as the raw material supplier did not provide an acceptable response to deroyal's request for completion of a supplier corrective action.It is not expected that another response from the vendor will be received.Corrective action: at deroyal, an inspection using aql standards was conducted of lot on hand for raw material 832894.The lot on hand passed inspection and no non-conformities were found.Investigation summary an internal complaint (call 47452) was received for a c-section pack (part 89-9205, lot 49830232) that contained a lap sponge that was discovered to contain a hair.This was noticed after the patient had already received her spinal for the procedure.The room had to be torn down and reset, resulting in a delay in the procedure.The defective sample was not available for return.The work order was reviewed for possible discrepancies that may have contributed to the reported event.No discrepancies were identified.The bill of materials was reviewed and the affected component was identified as raw material 832894, which is supplied to deroyal by covidien.The raw material sponges come to deroyal in a bundled pack of 5.These packs are not opened during the kit assembly process.Due to the reported location of the hair and the fact that the sponge packs are not unbundled by deroyal, it was determined that the hair contamination source was not the kit assembly process.Due to the nature of the reported incident, a supplier corrective action request was issued to covidien.On july 15, 2019, deroyal received a letter from covidien stating it will not investigate the complaint due to the absence of a sample.The investigation is complete at this time.If new and critical information is received, this report will be updated.
Event or Problem Description
A hair was found on a lap sponge contained in a c-section pack.The room had to be torn down and reset, creating a delay in the procedure.This occurred after the patient had already received her spinal.

• Brand Name: C-SECTION PACK
• Common Device Name: KIT, SURGICAL INSTRUMENT, DISPOSABLE
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central avenue; lafollette TN 37766
• MDR Report Key: 8780702
• Report Number: 3005011024-2019-00007
• Device Sequence Number: 2014412
• Product Code: KDD
• UDI-Device Identifier: 00749756905046
• UDI-Public: 00749756905046
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: EXEMPT
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 89-9205
• Device Lot Number: 49830232
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 06/13/2019
• Supplement Date Received by Manufacturer: 06/13/2019
• Initial Report FDA Received Date: 07/11/2019
• Supplement Report FDA Received Date: 09/26/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1