FDA Adverse Event
Malfunction
Summary report: N
BD PHASEAL Y-SITE CONNECTOR (C80)
MDR report key: 12610589
·
Received October 11, 2021
Report
- Report Number
- 3003152976-2021-00678
- Event Type
- Malfunction
- Date Received
- October 11, 2021
- Date of Event
- August 16, 2021
- Report Date
- September 14, 2021
- Manufacturer
- BECTON DICKINSON, S.A.
- Product Code
- ONB
- UDI-DI
- 30382905153045
- PMA / PMN Number
- K123213
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
A DEVICE EVALUATION IS ANTICIPATED BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
Description of Event or Problem · 1
IT WAS REPORTED THAT 2 BD PHASEAL¿ Y-SITE CONNECTORS (C80) LEAKED DURING USE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM (B)(6) TO ENGLISH: "WE GOT AN RECLAMATION ABOUT THE 515304 LOT:2103205 FROM THE LAST DELIVERY ON 2 EACHES, LIQUID DRIPS SIDEWAYS."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1505851 | BD PHASEAL Y-SITE CONNECTOR (C80) | INTRAVASCULAR ADMINISTRATION SET | ONB | BECTON DICKINSON, S.A. | 515304 | 2103205 | 30382905153045 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |