MAUDE Adverse Event Report: CHEMOSAFELOCK BAG SPIKE; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number KL-BS001

Device Problems Fluid/Blood Leak (1250); Material Puncture/Hole (1504)

Patient Problems Chemical Exposure (2570); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 08/03/2021

Event Type  malfunction  

Manufacturer Narrative

The device is available for evaluation.It has not been received.

Event Description

The event involved a chemosafelock bag spike that the customer reported the akpra leaked from the top of the connector.A hole was confirmed by the customer on the top surface of the bag spike.When inserted into a saline bag, leakage was confirmed from the top surface of the bag spike, this was simulated.The event occurred after stabbing and was used for infusion and injection procedures.There was a report of an unprotected chemotherapy exposure to the nurse on the nurse's body.The exposed portion was rinsed off with water and the health condition of the nurse is being monitored.There was no medical intervention reported.There was no patient involvement and no report of harm.This captures the first of two events.

Manufacturer Narrative

Received one used list #kl-bs001, chemosafelock bag spike; lot #5103354 was received for evaluation on september 8, 2021.The sample had a hole in the center of the over-molded tip of the chemolock port spike.The hole resulted in leakage during priming.The reported complaint can be confirmed on the chemosafelock bag spike.The probable cause of the complaint is due to silicone build-up on the tips of the molding tool core pins over time.The lot history was reviewed and no nonconformities were identified that may have contributed to the reported complaint.

• Brand Name: CHEMOSAFELOCK BAG SPIKE
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• MDR Report Key: 12406014
• MDR Text Key: 270667319
• Report Number: 9617594-2021-00242
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00000000
• UDI-Public: (01)00000000(17)231201(10)5103354
• Combination Product (y/n): N
• PMA/PMN Number: K081361
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,distri
• Type of Report: Initial,Followup
• Report Date: 08/04/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/01/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/01/2023
• Device Catalogue Number: KL-BS001
• Device Lot Number: 5103354
• Was Device Available for Evaluation?: Yes
• Date Manufacturer Received: 09/30/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Treatment: AKPRA, MFR UNK