MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC. MEDLINE INDUSTRIES, INC.; DBD-T & A PACK

Model Number	DYNJ40585D
Health Effect - Clinical Code	Superficial (First Degree) Burn (2685)
Date of Event	05/14/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported, that during a surgical adenoidectomy procedure, a (b)(6) female patient sustained an "apparent posterior tongue superficial burn from a suction coagulator/bovie".The reporter states the patient incurred "mild harm".There was no report of serious injury, follow-up care provided or medical intervention required related to this incident.The sample has not been returned therefore a root cause has not been established.There is no further information.Due to the reported incident 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, that during surgical procedure (adenoidectomy), a (b)(6) female patient sustained a burn from the suction coagulator/bovie.
Additional Manufacturer Narrative
Changed/additional information added.D9 device available for evaluation -yes, date returned to manufacturer - 6/11/2020.G6 type of report - follow-up.H3 device evaluated by manufacturer - yes, evaluation summary attached.H2 if follow-up what type? device evaluation.H6 type of investigation- 4101, 4110, 4113.H5 investigation conclusion - cause/zcd00003/defect confirmed: supplier mfg./error (non-medline branded).H10 investigation report reads as follows, 06/25/2020 11:34:53 cst phone (b)(6).Sample evaluation: the sample of the suction bovie was received for our investigation, the rest of the pack was not returned at this time.Upon inspection of the received sample, no physical damage was seen on the device.Dhr/bom reviewed: no non-conformances were noted that would have contributed to the reported issue.Bovie is placed on top of the mayo stand cover.Trending: trending was reviewed and there have been 0 additional reported complaint(s) for this issue in the past 6 months.Investigation summary: the account reported finding suction bovie burned patients tongue.The reported issue occurred in item dynj40585d (lot 19ida235).Since we do not own the specifications for this device this is considered a vendor product issue and the complaint details have been forwarded to the vendor for further evaluation.
Event or Problem Description
It was reported, that during surgical procedure (adenoidectomy), a two-year old female patient sustained a burn from the suction coagulator/bovie.

• Brand Name: MEDLINE INDUSTRIES, INC.
• Common Device Name: DBD-T & A PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield, il
• MDR Report Key: 10147988
• Report Number: 1423395-2020-00009
• Device Sequence Number: 14416211
• Product Code: OGR
• UDI-Device Identifier: 10889942624515
• UDI-Public: 10889942624515
• Combination Product (Y/N): N
• 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,user f
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/21/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: DYNJ40585D
• Device Catalogue Number: DYNJ40585D
• Device Lot Number: 19IDA235
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/11/2020
• Initial Date Received by Manufacturer: 05/20/2020
• Supplement Date Received by Manufacturer: 05/20/2020
• Initial Report FDA Received Date: 06/12/2020
• Supplement Report FDA Received Date: 01/21/2021
• 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: Other
• Patient Age: 2 YR