MAUDE Adverse Event Report: SUZHOU AVON TEXTILE CO. LTD. PEANUT SPONGE; GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE

Model Number 30-106

Device Problems Material Separation (1562); Material Integrity Problem (2978)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 03/30/2017

Event Type  malfunction  

Manufacturer Narrative

An internal complaint ((b)(4)) was received indicating that a peanut sponge (part number 30-106) came apart during a surgical procedure.The sample was unavailable for return.The raw material sponge is supplied to deroyal by (b)(4).Therefore, a supplier corrective action request was issued may 3 to (b)(4).A response was received may 9.The investigation is ongoing at this time.When new and critical information is received, this report will be updated.

Event Description

The product came apart during surgery.The nurse saw that it left a small piece of material, but the staff removed it.

Manufacturer Narrative

Root cause: based on the complaint description, this has been determined to be a vendor issue.A supplier corrective action request (scar) was issued to the sponge manufacturer, a-plus international.In its response, a-plus stated the complaint information was forwarded to the factory to increase their awareness for similar incidents.To ensure the factory's inspection procedures are effective, they have instructed their inspectors to pay special attention when performing the inspection of in-process and finished product.They will continue to monitor this complaint and implement additional corrective/preventive actions as necessary.An internal complaint (b)(4) was received indicating that a peanut sponge (part number 30-106) came apart during a surgical procedure.The sample was unavailable for return.Process records were reviewed and no issues related to the sponge were found during work order processing.Quality control inspection of the referenced lot number did not show any issues.A total 315 packs of the 32,100 packs produced during the work order were checked.A work in process evaluation also was performed and did not show any issues.The raw material sponge is supplied to deroyal by a-plus international.Therefore, a supplier corrective action request was issued may 3 to a-plus and a response was received.A total of (b)(4) packs for the part referenced in the complaint were sold from (b)(6) 2015, to (b)(6) 2017.A total of 206 packs have been reported with issues during the same time period.The complaint-to-sales ratio is 0.01%.Preventive action: a preventive action has not been taken.

Event Description

The product came apart during surgery.The nurse saw that it left a small piece of material, but the staff removed it.

• Brand Name: PEANUT SPONGE
• Type of Device: GAUZE/SPONGE, INTERNAL, X-RAY DETECTABLE
• Manufacturer (Section D): SUZHOU AVON TEXTILE CO. LTD.; yuanhe town; xiangcheng region; suzhou city, jiangsu 21513 3; CH 215133
• Manufacturer (Section G): ORTHO AND SURGICAL PRODUCTS ENTERPRISES S.A.; km 20.5 carretera; a villa canales; villa canales, guatemala 01065 ; GT 01065
• Manufacturer Contact: sarah bennett ; 200 debusk lane; powell, TN 37849 ; 8653626112
• MDR Report Key: 6579119
• MDR Text Key: 75728495
• Report Number: 3010452421-2017-00003
• Device Sequence Number: 1
• Product Code: GDY
• 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: Other
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date: 01/19/2018

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
• Device Operator: Health Professional
• Device Model Number: 30-106
• Device Lot Number: 40417599
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 04/19/2017
• Initial Date FDA Received: 05/19/2017
• Supplement Dates Manufacturer Received: 04/19/2017
• Supplement Dates FDA Received: 01/22/2018
• 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