MAUDE Adverse Event Report: GOODWOOD MEDICAL CARE LTD PROCTO SWAB; APPLICATOR, ABSORBENT TIPPED, STERILE

Model Number 31-249

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

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 03/28/2019

Event Type  malfunction  

Manufacturer Narrative

An internal complaint (call (b)(6) was received indicating the cotton tip of a procto swab (part 31-249, lot 47346703) became dislodged inside a patient.The investigation is ongoing at this time.When new and critical information becomes available, this report will be updated.

Event Description

The cotton end of a swab broke off and stayed stuck inside of patient during disinfection.

Event Description

The cotton end of a swab broke off and stayed stuck inside of patient during disinfection.

Manufacturer Narrative

Root cause: the swab is supplied to deroyal by international medsurg.Therefore, a supplier corrective action request (scar) was issued to international medsurg.In its response, the supplier stated the manufacturing facility reviewed production records and found no instance any non-conformity in the reported lot.The manufacturing facility identified a potential root cause of inadequate glue applied to the shaft during production.Corrective action: in its scar response, the supplier stated the current inventory was inspected and no defective product was found.All workshops, production associates, and the process inspector were informed of the complaint.A glue inspection log was implemented and supervisor oversight was increased.Production workers and directors and the process inspector were trained on the new log.The shaft will be inspected per a revised specification standard.Investigation summary: an internal complaint (b)(4) was received indicating the cotton tip of a procto swab (part 31-249, lot 47346703) became dislodged inside a patient.The sample was not available for evaluation.Quality records were reviewed, but no defects were identified that could have contributed to the reported event.An inventory check was performed with 12 cases randomly inspected.No issues were found.The swab is supplied to deroyal by international medsurg.Therefore, a supplier corrective action request (scar) was issued to international medsurg.A response was received february 27, 2020 and accepted by deroyal personnel.A total of (b)(4) packs for the reported part number have been sold between january 2018 and march 2020.With the exception of the reported incident, no similar issues for this part number have been reported during the same time period.The investigation is complete at this time.If new and critical information becomes available, this report will be updated.

• Brand Name: PROCTO SWAB
• Type of Device: APPLICATOR, ABSORBENT TIPPED, STERILE
• Manufacturer (Section D): GOODWOOD MEDICAL CARE LTD; 1-2 floor, 3-919 jiulicun; yongzheng street, jinzhou dist; dalian, liaoning 11610 0; CH 116100
• MDR Report Key: 9673511
• MDR Text Key: 200686080
• Report Number: 3010452421-2020-00001
• Device Sequence Number: 1
• Product Code: KXG
• UDI-Device Identifier: 50749756028610
• UDI-Public: 50749756028610
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 04/14/2020

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: 31-249
• Device Lot Number: 47346703
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/09/2020
• Initial Date FDA Received: 02/05/2020
• Supplement Dates Manufacturer Received: 01/09/2020
• Supplement Dates FDA Received: 04/15/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1