MAUDE Adverse Event Report: MEDLINE INDUSTRIES, INC.; XRAY DETECTABLE GAUZE FROM LAMINECTOMY SPINE PACK

Catalog Number	DYNJ904139D
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/05/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
It was reported that in the middle of a lumbar fusion procedure, hair was noted in one of the x-ray detectable sponges.This x-ray detectable sponge that reportedly has hair woven into it was in the middle of the pack of sponges.Prior to the case, the sponges were reportedly not inspected due to not having the time to thoroughly look through every single item in the custom surgical pack.It was reported that the sponge with hair did not reach the patient's open wound because hair was noticed before the surgeon used the sponge.However, the scrub staff reportedly had touched the sponges and had been touching all of the implants that were used for the procedure.The sponge with hair was immediately taken off the surgical field and the patient's surgical site was thoroughly irrigated.General anesthesia was used; however, there was no report of any adverse patient consequence and no effect on the patient's stability as a result of the incident.No impact to the patient, the procedure, or the total length of the procedure was reported.Due to reported need for irrigation and in an abundance of caution, this medwatch is being filed.The sample is not available to be returned for evaluation.A 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 or Problem Description
It was reported that in the middle of a lumbar fusion procedure, hair was noted in one of the x-ray detectable sponges.

• Common Device Name: XRAY DETECTABLE GAUZE FROM LAMINECTOMY SPINE PACK
• Manufacturer (Section D): MEDLINE INDUSTRIES, INC.; three lakes drive; northfield IL 60093
• MDR Report Key: 7921974
• Report Number: 1423395-2018-00050
• Device Sequence Number: 13883680
• Product Code: OJH
• UDI-Device Identifier: 10889942889990
• UDI-Public: 10889942889990
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/01/2018

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 Catalogue Number: DYNJ904139D
• Device Lot Number: 18FBS220
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 09/05/2018
• Initial Report FDA Received Date: 10/01/2018
• 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
• Patient Age: 56 YR
• Patient Weight: 82