FDA Adverse Event
Malfunction
Summary report: N
DALE ACE CONNECTOR
MDR report key: 4358359
·
Received December 18, 2014
Report
- Report Number
- 1214422-2014-00002
- Event Type
- Malfunction
- Date Received
- December 18, 2014
- Date of Event
- September 26, 2014
- Report Date
- December 18, 2014
- Manufacturer
- DALE MEDICAL PRODUCTS, INC.
- Product Code
- KNT
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
MAKE CONTACT WITH THE USER FACILITY ON 12/16/2014. DALE HAS SENT PRE-PAID MAILER TO FACILITATE RETURN OF THE PRODUCT. WILL UPDATE THIS MDR AFTER THE PRODUCT IS RETURNED AND EVALUATED.
Description of Event or Problem · 1
REFERENCE MDR (B)(4). ON 12/04/2014, DALE MEDICAL RECEIVED A COPY OF THE NOTED MDR FROM THE FDA STATING THE NOTED FACILITY REPORTED THAT THE DALE ACE CONNECTOR WAS LEAKING DURING TUBE FEEDING WITH FLUID LEAKING ONTO PATIENT AND BEDDING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 834702 | DALE ACE CONNECTOR | ENTERNAL FEEDING CONNECTOR | KNT | DALE MEDICAL PRODUCTS, INC. | 475 | T14M68900 14585 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |