MAUDE Adverse Event Report: MEDLINE INDUSTRIES INC.; SPONGE,LAP,8"X36",XRAY,ST,5/PK,40PK/CS

Catalog Number	MDS251536LF
Medical Device Problem Code	Protective Measures Problem (3015)
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 that the x-ray detectable (xrd) lap sponge was found to not be xrd during an anterior lumbar interbody fusion with fluoroscopy procedure.Reportedly, the xrd lap sponge was used to pack the surgical site and, when a fluoroscopy image was obtained, the lap sponge could not be visualized on the image.The packed lap sponge was subsequently removed from the surgical site and new product was obtained for the procedure.According to the reporting facility, the lap sponge count remained equal throughout the procedure and there was no adverse patient impact related to the incident.No sample has been received for evaluation.A root cause has been unable to be determined.Due to the reported incident, and in an abundance of caution, this medwatch is being filed.If additional relevant information becomes available a supplemental medwatch will be filed.
Event or Problem Description
It was reported that the x-ray detectable (xrd) lap sponge was found to not be xrd.

• Common Device Name: SPONGE,LAP,8"X36",XRAY,ST,5/PK,40PK/CS
• Manufacturer (Section D): MEDLINE INDUSTRIES INC.; three lakes drive; northfield IL 60093 2753
• MDR Report Key: 11929606
• Report Number: 1417592-2021-00090
• Device Sequence Number: 4662397
• Product Code: GDY
• UDI-Device Identifier: 00080196743905
• UDI-Public: 00080196743905
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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: health professional,other,use
• Initial Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date (Section B): 06/03/2021

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 Catalogue Number: MDS251536LF
• Device Lot Number: 26020090001
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/12/2021
• Initial Report FDA Received Date: 06/03/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 58 YR
• Patient Weight: 84