MAUDE Adverse Event Report: BD MEDICAL - DIABETES CARE BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE; PISTON SYRINGE

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.

• Brand Name: BD INSULIN SYRINGE WITH THE BD ULTRA-FINE NEEDLE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BD MEDICAL - DIABETES CARE; 1329 west highway 6; holdrege NE 68949
• MDR Report Key: 9439820
• MDR Text Key: 172288217
• Report Number: 2243072-2019-02766
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 12/13/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/09/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 320440
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/20/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention