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

Model Number 89-8636

Device Problem Device Contaminated During Manufacture or Shipping (2969)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 08/03/2017

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: an internal complaint (b)(4) was received indicating that a c-section pack (finished good 89-8636, lot 44274011) contained a drape with a piece of plastic on it.The affected drape was identified as a c-section drape with pouch and fenestration (b)(4).The sample was initially reported to be available for return.However, due to the contamination of the sample, it was not returned for evaluation.Instead, a photograph of the reported defect was sent.The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.Lot mapping identified the raw material drape used in the reported finished good lot was supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was issued august 10, 2017, to (b)(4).The photograph of the reported defect also was sent to the supplier.The supplier acknowledged receipt of the scar on august 16, 2017.A response is due september 21, 2017.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

A piece of plastic was found on a c-section drape with pouch and fenestration during a procedure.The procedure was delayed while a new pack was opened.

Manufacturer Narrative

Root cause: the convenience kit component is supplied to deroyal by welmed.Therefore, a supplier corrective action request (scar) was issued to welmed.In its response, welmed said the lot number provided indicates the drape was manufactured seven years ago.It is unable to perform a thorough investigation of the device history record as it has been discarded due to age.Corrective action: in its scar response welmed stated, due to a preliminary risk assessment, it believes this is a low risk failure due to not experiencing this issue before.Based on volume produced, welmed does not believe a change to specifications or production measures is necessary at this time.It has documented the issue for trending and will continue to monitor the situation in capa.An internal complaint (b)(4) was received indicating that a c-section pack (finished good 89-8636, lot 44274011) contained a drape with a piece of plastic on it.The affected drape was identified as a c-section drape with pouch and fenestration (raw material (b)(4).The sample was initially reported to be available for return.However, due to the contamination of the sample, it was not returned for evaluation.Instead, a photograph of the reported defect was sent.The work order for the reported lot number was reviewed for discrepancies that may have contributed to the reported event.No discrepancies were identified.Lot mapping identified the raw material drape used in the reported finished good lot was supplied to deroyal by welmed.Therefore, a scar was issued (b)(6) 2017, to welmed.The photograph of the reported defect also was sent to the supplier.A response to the scar has been received.The investigation is complete at this time.If new and critical information is received, this report will be updated.

Event Description

A piece of plastic was found on a c-section drape with pouch and fenestration during a procedure.The procedure was delayed while a new pack was opened.

• Brand Name: C-SECTION 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: 6833556
• MDR Text Key: 85784064
• Report Number: 3005011024-2017-00012
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/31/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 89-8636
• Device Lot Number: 44274011
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 08/03/2017
• 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