MAUDE Adverse Event Report: CAREFUSION, INC PARACERVICAL PUD TRAY CONTROL SYRINGE; SET, ANESTHESIA, PARACERVICAL

Catalog Number 4540A

Device Problem Leak/Splash (1354)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2019

Event Type  malfunction  

Manufacturer Narrative

Pr (b)(6) initial emdr submission.A follow up emdr will be submitted if additional information becomes available.(b)(4).

Event Description

Via email: medication squirts out from the connection between the syringe and needle.Needle gets easily disconnected from the non-luer lock syringe.Product used for cervical block by gyn doctors.No harm to patient.

• Brand Name: PARACERVICAL PUD TRAY CONTROL SYRINGE
• Type of Device: SET, ANESTHESIA, PARACERVICAL
• Manufacturer (Section D): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer (Section G): CAREFUSION, INC; zona franca las americas; santo domingo
• Manufacturer Contact: anna wehrheim ; 75 n. fairview drive; vernon hills, IL 60061 ; 8015652341
• MDR Report Key: 9355210
• MDR Text Key: 207343214
• Report Number: 9680904-2019-00024
• Device Sequence Number: 1
• Product Code: HEE
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NONE
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Reporter Occupation: Other Health Care Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date: 11/21/2019

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?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 4540A
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/28/2019
• Initial Date FDA Received: 11/21/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other