FDA Adverse Event
Malfunction
Summary report: N
MAXPLUS NEEDLELESS CONNECTOR
MDR report key: 3252607
·
Received July 15, 2013
Report
- Report Number
- 9616066-2013-00539
- Event Type
- Malfunction
- Date Received
- July 15, 2013
- Date of Event
- June 19, 2013
- Report Date
- June 20, 2013
- Manufacturer
- CAREFUSION CORP
- Product Code
- FPA
- PMA / PMN Number
- K072542
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- Reporter Occupation
- NURSE
Narratives
Additional Manufacturer Narrative · 1
(B)(4). THE AFFECTED PRODUCT HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE CONNECTION BETWEEN THE CAP AND TUBING CAME LOOSE AFTER MANIPULATION DURING ATTACHING AND DETACHING SYRINGES/TUBING. THE CONNECTION TO THE CAP WAS SECURED WITH TAPE BUT CHEMOTHERAPY LEAKED AT THE MALE LUER SIDE. THERE WAS NO PT HARM REPORTED AND NO MEDICAL INTERVENTION WAS REQUIRED. CUSTOMER STATED THAT NO ADDITIONAL PT OR EVENT DETAILS ARE AVAILABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 327561 | MAXPLUS NEEDLELESS CONNECTOR | FPA | CAREFUSION CORP | MP1000-C | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | BARD POWERLOC MAX PORT: MODEL AND LOT # UNK |