MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SPONGE STICK IN WET SKIN SCRUB KIT

Catalog Number DYND70760

Device Problem Detachment of Device or Device Component (2907)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Code Available (3191)

Event Date 04/06/2019

Event Type  malfunction  

Manufacturer Narrative

It was reported that during prep for a dilatation and curettage, the sponge stick (from wet skin scrub kit) came off the sponge and sponge was stuck in the patient's vagina.Per report, prior to the incident, the sponge stick was soaked with betadine paint and was immediately used to prep the patient.During inspection prior to use, it was denied that any issue with the sponge stick was identified at that time.The sponge was successfully retrieved from inside the patient's vagina through manual retrieval using the staff's fingers/hand.Due to the reported event and medical intervention required to retrieve the sponge from inside the patient's vagina, this medwatch is being filed.The sample is not available to be returned for evaluation.A definitive root cause could not be determined at this time.No additional information is available.If additional information becomes available, a supplemental medwatch will be filed.

Event Description

It was reported that during prep for a dilatation and curettage, the sponge stick came off the sponge and sponge was stuck in the patient's vagina.

• Type of Device: SPONGE STICK IN WET SKIN SCRUB KIT
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• Manufacturer Contact: bermon punzalan ; three lakes drive; northfield, IL 60093
• MDR Report Key: 8712991
• MDR Text Key: 150277881
• Report Number: 1417592-2019-00097
• Device Sequence Number: 1
• Product Code: LRO
• UDI-Device Identifier: 10080196853236
• UDI-Public: 10080196853236
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,user f
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 06/19/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: DYND70760
• Device Lot Number: 181B0711
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/21/2019
• 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 Outcome(s): Required Intervention