MAUDE Adverse Event Report: CENTURION; PORT ACCESS TRAY

Catalog Number	DT19365
Medical Device Problem Code	Connection Problem (2900)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/22/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the facility on 10/22, "one of our patients was receiving a chemotherapy infusion.The chemotherapy was initiated and after a few minutes the patient noted her shirt was wet.Another rn and myself went to patient's chairside and stopped the infusion and noticed the connection at the clave and the iv tubing became unthreaded and was dripping chemotherapy onto the patient.Our md was notified and after further investigation by the rn and pharmacist it was determined the patient may only have had about 5 ccs of actual chemotherapy wasted, so our md just ordered the rns to give the patient the remainder of the dose".The facility stated that after the "incident occurred the chemotherapy was stopped, the md was notified, the pharmacist was notified, and the patient was brought to the bathroom to change her shirt and wash her hands.A different brand of clave was attached to the safe step huber needle".The facility continued to state that there was "no serious injury identified.The patient was called the next day by this rn and was "doing good" per patient report".The device that was used is not available for evaluation.It has been determined that the reported event could cause or contribute to serious injury if it were to occur.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
According to the facility on 10/22, "one of our patients was receiving a chemotherapy infusion.The chemotherapy was initiated and after a few minutes the patient noted her shirt was wet.

• Common Device Name: PORT ACCESS TRAY
• Manufacturer (Section D): CENTURION; tri-state de mexico; s. de r.l. de c.v; mexicali, baja california 21397 ,; MX 21397,
• Manufacturer Contact: alex mathew ; three lakes drive; northfield, IL 60093-2753 ; 2249317042
• MDR Report Key: 20750463
• Report Number: 3004519921-2024-00044
• Device Sequence Number: 4399680
• Product Code: OXQ
• UDI-Device Identifier: 10653160280309
• UDI-Public: 10653160280309
• Combination Product (Y/N): N
• Initial Reporter State: MT
• 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
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 11/21/2024

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?: No
• Device Catalogue Number: DT19365
• Device Lot Number: 2024070590
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/23/2024
• Initial Report FDA Received Date: 11/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown