MAUDE Adverse Event Report: UNKNOWN SYRINGE TIP CAP; ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS

Device Problems Break (1069); Entrapment of Device (1212); Mechanical Jam (2983); Fail-Safe Did Not Operate (4046)

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

Event Type  Other  

Event Description

We had an event at xxxxxxx xxxxxxxxx that we wanted to bring to your attention for possible submission to the (b)(6) newsletter.Please see sbar below.It is in regards to tamper evident caps used for oral solution controlled substances and the inside tip of the cap breaking off and becoming lodged in the tip of the syringe.In this case, the nurse was prevented from pressing down on the plunger and did not administer the product to the patient though the concern is that these caps are widely used and a different nurse might not notice and this could lead to a choking hazard in pediatric and elderly patients.Please let us know if you have any questions.Situation: received a report from pediatric intensive care unit (picu) that the syringe tip cap had been lodged in an oral solution and the nurse was unable to press the plunger to deliver the medication to the patient.This occurred on two syringes and a third syringe was obtained to administer the medication.Background: these are specially designed tamper evident caps used across the institution on a variety of different products and also utilized by 503b outsourcers when compounding controlled substances in an oral solution form.(b)(6).Submission id: (b)(4).Reference report: mw5117894.

• Brand Name: SYRINGE TIP CAP
• Type of Device: ENTERAL SYRINGES WITH ENTERAL SPECIFIC CONNECTORS
• Manufacturer (Section D): UNKNOWN
• MDR Report Key: 17010168
• MDR Text Key: 316151148
• Report Number: MW5117895
• Device Sequence Number: 1
• Product Code: PNR
• 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: 05/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/25/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Patient Sequence Number: 1