Catalog Number 320440 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problems
Vitreous Floaters (1866); Foreign Body In Patient (2687)
|
Event Date 10/02/2019 |
Event Type
Injury
|
Manufacturer Narrative
|
There are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.Device manufacture date: unknown.
|
|
Event Description
|
Material no.: unknown.Batch no.: unknown.It was reported that after use of the unspecified bd insulin syringe silicone oil came out of the syringe during a right eye injection.Male patient with the initials (b)(6) had a right eye injection (b)(6) 2019."floaters" were reported to our staff (b)(6) 2019.He saw dr.((b)(6) 2019) and was confirmed to have silicone oil.We will be seeing him again in (b)(6) for ongoing treatment.The following information was provided by the initial reporter: we have another diagnosed case of silicone oil bubbles post injection.Male patient with the initials (b)(6) had a right eye injection (b)(6) 2019."floaters" were reported to our staff (b)(6) 2019.He saw dr.((b)(6) 2019) and was confirmed to have silicone oil.We will be seeing him again in (b)(6) for ongoing treatment.
|
|
Event Description
|
Material no.: 320440; batch no.: unknown.It was reported that after use of the unspecified bd insulin syringe silicone oil came out of the syringe during a right eye injection.Male patient with the initials rl had a right eye injection on (b)(6) 2019."floaters" were reported to our staff nov 7/19.He saw dr.(b)(6) 19) and was confirmed to have silicone oil.We will be seeing him again in jan for ongoing treatment.The following information was provided by the initial reporter: we have another diagnosed case of silicone oil bubbles post injection.Male patient with the initials rl had a right eye injection (b)(6) 2019."floaters" were reported to our staff (b)(6) 19.He saw dr.(b)(6) 19) and was confirmed to have silicone oil.We will be seeing him again in (b)(6) for ongoing treatment.
|
|
Manufacturer Narrative
|
D.1.Medical device brand name: bd insulin syringe with the bd ultra-fine¿ needle.D.3.Medical device manufacturer: bd medical - diabetes care.D.4 medical device catalog #: 320440.D.4.Unique identifier (udi) #: (b)(4); h3 other text : see section h.10.
|
|
Event Description
|
Material no.: unknown; batch no.: unknown.It was reported that after use of the unspecified bd insulin syringe silicone oil came out of the syringe during a right eye injection.Male patient with the initials rl had a right eye injection (b)(6) 2019."floaters" were reported to our staff (b)(6) 19.He saw dr.(b)(6) 19) and was confirmed to have silicone oil.We will be seeing him again in jan for ongoing treatment.The following information was provided by the initial reporter: we have another diagnosed case of silicone oil bubbles post injection.Male patient with the initials rl had a right eye injection oct 2, 2019."floaters" were reported to our staff nov 7/19.He saw dr.(nov 20/19) and was confirmed to have silicone oil.We will be seeing him again in jan for ongoing treatment.
|
|
Manufacturer Narrative
|
H.6.Investigation: no samples (including photos) were returned therefore the complaint could not be confirmed and the root cause is undetermined.Unable to perform dhr check for foreign matter in eye (silicone) due to unknown lot number.H3 other text : see h.10.
|
|
Search Alerts/Recalls
|