MAUDE Adverse Event Report: GOODWOOD MEDICAL CARE LTD. PROCTO SWAB; APPLICATOR

Catalog Number 31-999

Device Problems Separation Failure (2547); Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923); Material Integrity Problem (2978)

Patient Problem Foreign Body In Patient (2687)

Event Date 01/18/2021

Event Type  malfunction  

Manufacturer Narrative

An internal complaint (call (b)(6)) was recieved indicating that the cotton swab end of the 6-inch procto swab (product id 31-999, lot 52161375) came off of the swab while being used in patient's vagina.Surgeon retrieved cotton tip/end, and searched vagina for additional cotton.Surg tech inspected both pieces of procto swab to ensure that all pieces of product was removed from body.The pieces were removed from the sterile field and placed in biohazard bag in the outer pocket of bag.The device was not returned for available evaluation to be able to complete a thorough investigation.The product development specialist has been contacted in order to inform the vendor and waiting on feedback.The investigation is incomplete at this time.Scar has been sent along with video of inspection of applicator, however still waiting for completion from vendor.We will provide a follow up if additional information becomes available.

Event Description

Cotton swab end of the 6-inch procto swab came off of the swab while being used in patient's vagina.Surgeon retrieved cotton tip/end, and searched vagina for additional cotton.Surg tech inspected both pieces of procto swab to ensure that all pieces of product was removed from body.Procto swab pieces were removed from the sterile field and placed in biohazard bag.Packaging was placed in outer pocket of bag.

Manufacturer Narrative

Investigation finding: as per device history record (dhr), there were 106 swab proctos that were found as defective due to extras in the material received, only 66 were in need to be replaced.Inventory check has been performed in 1 case for inspection.Tips do not come off without excessive force, unless if tips are wet, they come off with less force.(b)(4).Root cause: manufacturing error.The potential root cause can be attributed to inconsistency of glue control when the machine turns on.If the individual applicator in the winding process is too loose it could cause the mix to mass produce, causing shedding.The supplier (international medsurg) reviewed production records and found no nonconformance during the production of this lot.No change in operators and equipment.Device history record (dhr) was reviewed and confirmed no deviation occurred during manufacturing process.No defective samples received from customer, however the factory performed testing from retention samples to check firmness of tip.The retention samples passed the test using current specification testing procedure.However, to prevent this non-conformance from reoccurring, the factory has revised its internal procedure.Corrective action: a supplier corrective action report (scar) was completed by supplier (international medsurg).It requires qc to randomly check cotton tip winding fastness daily per standard requirement.Process inspectors and production associates were informed of the complaint and understood the inspection documents change.An update for in-process inspection and release product inspection procedures to add the tip firmness test when wet.Also qc and operators were trained on procedures and inspection sampling plan updates.Control of glue usage amount per internal standard before turning on or restart the machine.The investigation is complete at this time.No further information is available at this time.We will provide follow up report if additional information becomes available.

• Brand Name: PROCTO SWAB
• Type of Device: APPLICATOR
• Manufacturer (Section D): GOODWOOD MEDICAL CARE LTD.; 1-2 floor, 3-919 jiulicun; yongzheng street; jinzhou district, dalian 11610 0,; CH 116100,
• MDR Report Key: 11475038
• MDR Text Key: 280460689
• Report Number: 3010452421-2021-00002
• Device Sequence Number: 1
• Product Code: KXG
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional
• Type of Report: Initial,Followup
• Report Date: 04/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: No Information
• Device Catalogue Number: 31-999
• Device Lot Number: 52161375
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/20/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 59 YR