MAUDE Adverse Event Report: NEXUS MEDICAL, LLC MALE/FEMALE RED END CAPS; SET, ADMINISTRATION, INTRAVASCULAR

Device Problem Defective Device (2588)

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

Event Type  Other  

Event Description

Red syringe caps: mfg# n9902r red end cap male/female; manufactured by nexus medical distributed by health care technology lot 22160; reported that there were 2 instances at hospital bone and joint where after applying the red cap to a syringe containing propofol, a pinkish tinted color of the white medication at the edge of the syringe where the cap was affixed was described.This does not usually occur.Staff reported the affected caps look to be a darker red color than other lots.All product with this lot was sequestered and not used.No affected product was used in patient care.Reference report: mw5117624.Outcome, no affected product was used in patient care.Where did the error occur, hospital.(b)(6).Submission id: (b)(4).

• Brand Name: MALE/FEMALE RED END CAPS
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): NEXUS MEDICAL, LLC
• MDR Report Key: 16952804
• MDR Text Key: 315575927
• Report Number: MW5117624
• Device Sequence Number: 1
• Product Code: FPA
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Unknown
• Type of Report: Initial
• Report Date: 05/17/2023

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?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/17/2023
• Patient Sequence Number: 1