FDA Adverse Event
Malfunction
Summary report: N
SLOW FLOW NIPPLE
MDR report key: 22009159
·
Received May 13, 2025
Report
- Report Number
- 22009159
- Event Type
- Malfunction
- Date Received
- May 13, 2025
- Date of Event
- February 9, 2025
- Report Date
- May 1, 2025
- Manufacturer
- ABBOTT NUTRITION
- Product Code
- FNN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- CT
- Reporter Occupation
- NURSE
- Health Professional
- Yes
Narratives
Description of Event or Problem · 0
WHILE BOTTLE FEEDING AN INFANT USING HOSPITAL SLOW NIPPLE, DISCOVERED THAT NIPPLE HAD NO OPENING. NOTICED INFANT SUCKING WITHOUT PROGRESS. I ASSESSED THE NIPPLE AND NOTED THERE WAS NO OPENING. MANUFACTURER RESPONSE FOR SLOW FLOW NIPPLE, SLOW FLOW NIPPLE (PER SITE REPORTER). [DATE REDACTED] SUBMIT DEFECTED ITEMS AND COMPLAINS THROUGH SALES REPRESENTATIVE. AFTER CONTACTING CONSUMER RELATIONS @ 800-850-7677 - THEY AGREED TO MAIL A BOX FOR SAMPLE WITH THEIR TRACKING NUMBER [TRACKING NUMBER REDACTED] [DATE REDACTED] MAILED VIA USPS TRACKING# [TRACKING # REDACTED].
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2369907 | SLOW FLOW NIPPLE | NIPPLE, LAMBS FEEDING | FNN | ABBOTT NUTRITION | 703053L00 | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |