Catalog Number 990175 |
Device Problem
Device Damaged Prior to Use (2284)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Date 12/13/2018 |
Event Type
malfunction
|
Manufacturer Narrative
|
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
|
|
Event Description
|
It was reported that a bd plastipak¿ syringe luer-lok¿ had a damaged stopper prior to use.
|
|
Manufacturer Narrative
|
Investigation summary: it was performed the dhr, quality notification and maintenance analysis and no occurrences potentially related to the defect was observed.The sample received was evaluated and submitted to validated test and no deviation were observed.Based on sample evaluation and tests performed it was not possible confirm the complaint.Thus it is not possible confirm the defect of this complaint was related of bd process.
|
|
Event Description
|
It was reported that a bd plastipak¿ syringe luer-lok¿ had a damaged stopper prior to use.
|
|
Manufacturer Narrative
|
The corrections are as follows: it was included that the device experienced leakage during use in addition to the previously reported stopper damage.
|
|
Event Description
|
It was reported that a bd plastipak¿ syringe luer-lok¿ had a damaged stopper prior to use.
|
|
Search Alerts/Recalls
|