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

Catalog Number 89-6284

Device Problems Material Fragmentation (1261); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/11/2016

Event Type  malfunction  

Manufacturer Narrative

The investigation is incomplete at this time.This report will be updated when more information becomes available.

Event Description

After receiving a 4x4 sponge from the surgical field, the scrub tech opened the sponge to find several small pieces of gauze sponge inside.No cutting from the original sponge was noted.The sponge had not been used on the open field.The wound was checked and irrigated.No pieces seen.Sponges were from deroyal vascular pack.

Manufacturer Narrative

Root cause: the affected raw material ((b)(4)) is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request (scar) was submitted to (b)(4).The true root cause is a visual inspection failure to remove the gauze containing sewn connections from the production line.Corrective action: the supplier stated in its scar response that workers are required to identify the sewn connections with color adhesive tapes to aid in visual detection.Investigation summary: a complaint ((b)(4)) was received indicating that (b)(4) (lot number 4070983) contained a gauze with small pieces of gauze sponge inside.The complaint was received through (b)(4).The work order was reviewed for discrepancies that would have contributed to the reported issue.No discrepancies were identified.The work order contained raw material (b)(4) (lot number gs1507b13).This raw material lot was supplied by (b)(4).The 2014-2016 scar and supplier notification letter logs were reviewed for similar complaints.None were identified as received for the vendor and failure mode reported, but due to the nature of the complaint, a scar was issued to (b)(4).The supplier responded july 13, 2016.Preventative: the supplier stated in its scar response that related personnel were notified and retrained on the appropriate quality standard and operating procedure to enhance quality awareness and operating skill.The supplier also contacted the raw material supplier to advise it to tighten control on the sewn connections.This investigation is complete.If new and critical information is received, this report will be updated.

Event Description

After receiving a 4x4 sponge from the surgical field, the scrub tech opened the sponge to find several small pieces of gauze sponge inside.No cutting from the original sponge was noted.The sponge had not been used on the open field.The wound was checked and irrigated.No pieces seen.Sponges were from deroyal vascular pack.

• Brand Name: ASC VASCULAR PACK PGYBK
• Type of Device: GENERAL SURGERY TRAY (KIT)
• Manufacturer (Section D): DEROYAL INDUSTRIES, INC.; 1501 east central ave.; 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: 5742723
• MDR Text Key: 47965869
• Report Number: 3005011024-2016-00010
• 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: Other
• Type of Report: Initial,Followup
• Report Date: 07/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/22/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 89-6284
• Device Lot Number: 40790983
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 05/23/2016
• 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
• Patient Age: 80 YR