MAUDE Adverse Event Report: MEDLINE INDUSTRIES LP; SCALPEL,STAINLESS STEEL,11,DISP,STERIL

Catalog Number MDS15211

Device Problem Degraded (1153)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/01/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported by the facility, that during the regularly scheduled removal of nexplanon device the clinician found that a number 11 blade from a sterile sealed package was rusted.The clinician was able to utilize another blade in order to complete the procedure.The physician provided care for the patient and a tetanus booster was provided to the patient.The patient reported no signs or symptoms of infection post procedure.The sample was not returned for evaluation.No additional information is available.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 Description

It was reported by the customer that a procedure was performed with a number 11 blade from a sterile sealed package.Post procedure it was noted that the blade was rusted.

• Type of Device: SCALPEL,STAINLESS STEEL,11,DISP,STERIL
• Manufacturer (Section D): MEDLINE INDUSTRIES LP; three lakes drive; northfield IL 60093
• Manufacturer Contact: karen trutsch ; three lakes drive; northfield, IL 60093
• MDR Report Key: 13594058
• MDR Text Key: 296474069
• Report Number: 1417592-2022-00018
• Device Sequence Number: 1
• Product Code: GES
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 02/24/2022

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
• Device Operator: Health Professional
• Device Catalogue Number: MDS15211
• Device Lot Number: Y02223
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/04/2022
• Initial Date FDA Received: 02/24/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 28 YR
• Patient Sex: Female
• Patient Weight: 61 KG