C.R. BARD, INC. (COVINGTON) -1018233 TOOMEY IRRIGATION SYRINGE 70ML WITH CATHETER TIP AND LUER TIP ADAPTERS, PLASTIC,
|
Back to Search Results |
|
Catalog Number 0038460 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Known Impact Or Consequence To Patient (2692)
|
Event Type
malfunction
|
Manufacturer Narrative
|
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
|
|
Event Description
|
It was reported that a hair was found within the syringe.
|
|
Manufacturer Narrative
|
The reported issue was confirmed, as manufacturing related.During the visual inspection a hair was noted inside the syringe.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use state the following: ¿irrigation syringe bulb type single use do not use if package is damaged.Do not resterilize.Warning: reuse and/or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of the device, which may lead to device failure, and/or lead to injury, illness or death of the patient.After use, this product may be a potential biohazard.Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations." (b)(4).
|
|
Event Description
|
It was reported that a hair was found within the syringe.
|
|
Search Alerts/Recalls
|
|
|