MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE SAFETY 3ML LL 22X1; PISTON SYRINGE

Catalog Number 307862

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

Unknown manufacturer: 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.Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported that after injection in eye, silicone was injected which remained in the eye and now is seeing "floaters" with an unspecified bd syringe.The following information was provided by the initial reporter: (3 of 3 complaints).It was reported that the patient received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".Additional info provided by dr.Office states, "pt is female.She had an injection into her right eye on (b)(6) 2019.We saw her in follow up on oct 15/19 where the diagnosis of retained silicone oil bubbles was confirmed by dr.We are seeing him again in nov for more imaging and treatment as usual.".

Manufacturer Narrative

Additional information was provided by customer regarding the product on this complaint.The product initially reported was in a different internal business unit.It has been determined that this complaint will be canceled.The new complaint has been submitted under mfr report# 1920898-2019-01322.H3 other text : see h.10.

Event Description

It was reported that after injection in eye, silicone was injected which remained in the eye and now is seeing "floaters" with an unspecified bd syringe.The following information was provided by the initial reporter: (3 of 3 complaints) it was reported that the patient received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".Additional info provided by dr.Office states, "pt is female.She had an injection into her right eye on oct (b)(6).We saw her in follow up on oct (b)(6) where the diagnosis of retained silicone oil bubbles was confirmed by dr.We are seeing him again in nov for more imaging and treatment as usual.".

Manufacturer Narrative

The following fields have been updated with additional information: b.5.Describe event or problem: it was reported that after injection in eye, silicone was injected which remained in the eye and now is seeing "floaters" with a bd syringe safety 3ml ll 22x1.The following information was provided by the initial reporter: (3 of 3 complaints).It was reported that the patient received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".Additional info provided by dr.Office states, "pt is female.She had an injection into her right eye on (b)(6)19.We saw her in follow up on (b)(6)19 where the diagnosis of retained silicone oil bubbles was confirmed by dr.We are seeing him again in nov for more imaging and treatment as usual." d.1.Medical device brand name: bd syringe safety 3ml ll 22x1.D.1 medical device type: n/a.D.2.Common device name: piston syringe.D.3.Medical device manufacturer: becton dickinson ind.Cirurgicas ltda ¿ curitiba, brazil/81170-230.D.4 medical device catalog #: 307862.D.4.Medical device lot #: 9014709.D.4.Medical device expiration date: 2024-01-31.D.4.Unique identifier (udi) #: (b)(4).G.2 manufacturing location: becton dickinson ind.Cirurgicas ltda ¿ curitiba, brazil/81170-230.G.5.Pma / 510(k)#:n/a.H.4.Device manufacture date: 2019-01-14.

Event Description

It was reported that after injection in eye, silicone was injected which remained in the eye and now is seeing "floaters" with a bd syringe safety 3ml ll 22x1.The following information was provided by the initial reporter: (3 of 3 complaints).It was reported that the patient received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".Additional info provided by dr.Office states, "pt is female.She had an injection into her right eye on (b)(6)19.We saw her in follow up on (b)(6)19 where the diagnosis of retained silicone oil bubbles was confirmed by dr.We are seeing him again in nov for more imaging and treatment as usual.".

• Brand Name: BD SYRINGE SAFETY 3ML LL 22X1
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba NJ 07417
• MDR Report Key: 9266715
• MDR Text Key: 165642150
• Report Number: 2243072-2019-02443
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/01/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 01/31/2024
• Device Catalogue Number: 307862
• Device Lot Number: 9014709
• Date Manufacturer Received: 10/17/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other