MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; TRAY,SKIN SCRUB,WET,NO GLOVES

Model Number	DYND70772
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/18/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, vaginal swab became detached from stick and required retrieval by the surgeon.Reporter states, "they were prepping the vagina and the sponge became detached from the swab stick.Sponge was removed" (how the sponge was retrieved from the patient was not disclosed to manufacturer).Reporter states, no serious injury or follow-up care was required.Sample has not been returned for evaluation.No further information is available.Due to the reported incident, medical intervention and in an abundance of caution, this medwatch is being filed.If any further relevant information is identified or obtained, a supplemental medwatch will be submitted.
Event or Problem Description
It was reported, vaginal swab became detached from stick and required retrieval.
Additional Manufacturer Narrative
Supplemental documentation changed/additional information added.D9 device available for evaluation -yes, returned 4/23/2021.G6 type of report - follow-up.H6 type of investigation-4101, 4109.H5 investigation conclusion - defect confirmed: supplier mfg./error asia (medline branded).H10 investigation report reads as follows: investigation summary: "04/30/2021 10:13:40 cst.(rpipes).Medline quality received one case of dynd70772 with the lot 201bg574 for evaluation.It was reported that the sponge was left in the patient.This concern was logged as qa 200434459.Per the clinical investigation, it was found that the vaginal swab became detached from the stick and required retrieval by the surgeon.At this time, this concern will be confirmed as it was reported that the sponge stick detached inside a patient.A root cause was unable to be determined.Our manufacturing site will be notified of the issue.A retrospective review of the past year for this product indicated that there have been no prior complaints in regards to this issue.The division will continue to monitor this issue for trending.A three case replacement of dynd70772 was issued to the account per no cost sales order (b)(4).Ok to close.".
Event or Problem Description
It was reported, vaginal swab became detached from stick and required retrieval.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: TRAY,SKIN SCRUB,WET,NO GLOVES
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 11608628
• Report Number: 1417592-2021-00050
• Device Sequence Number: 11612187
• Product Code: OJU
• UDI-Device Identifier: 10080196844517
• UDI-Public: 10080196844517
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/30/2021

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
• Operator of Device: Health Professional
• Device Model Number: DYND70772
• Device Catalogue Number: DYND70772
• Device Lot Number: 201BG574
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2021
• Initial Date Received by Manufacturer: 03/18/2021
• Supplement Date Received by Manufacturer: 03/18/2021
• Initial Report FDA Received Date: 04/02/2021
• Supplement Report FDA Received Date: 04/30/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention