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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE SAFETY 3ML LL 22X1; PISTON SYRINGE
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BECTON DICKINSON IND. CIRURGICAS LTDA BD SYRINGE SAFETY 3ML LL 22X1; PISTON SYRINGE Back to Search Results
Catalog Number 307862
Device Problem Device Contamination with Chemical or Other Material (2944)
Patient Problem Vitreous Floaters (1866)
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.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, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It was reported that during eye injection silicone was injected and now they see "floaters" with an unspecified bd syringe.The following information was provided by the initial reporter: (1 of 3 complaints) it was reported by the patient that they received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".
 
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# 1920898-2019-01321.H3 other text : see h.10.
 
Event Description
It was reported that during eye injection silicone was injected and now they see "floaters" with an unspecified bd syringe.The following information was provided by the initial reporter: (1 of 3 complaints) it was reported by the patient that they received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".
 
Manufacturer Narrative
The following fields were updated with additional information: b.3.Date of event: (b)(6) 2019.B.5.Describe event or problem: it was reported that during eye injection silicone was injected and now they see "floaters" with an unspecified bd syringe.The following information was provided by the initial reporter: (1 of 3 complaints) it was reported by the patient that they received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".Additional information provided by dr.Office states, "the male pt, hf, had an injection into his right eye on (b)(6) 19.We saw him in follow up on oct 8/19 where the diagnosis of retained silicone oil bubbles was confirmed by dr.We are seeing him again (b)(6) 19 for more imaging and treatment." h3 other text : see h.10.
 
Event Description
It was reported that during eye injection silicone was injected and now they see "floaters" with an unspecified bd syringe.The following information was provided by the initial reporter: (1 of 3 complaints) it was reported by the patient that they received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".Additional information provided by dr.Office states, "the male pt, had an injection into his right eye on (b)(6) 19.We saw him in follow up on (b)(6) 19 where the diagnosis of retained silicone oil bubbles was confirmed by dr.We are seeing him again (b)(6) 19 for more imaging and treatment.".
 
Event Description
It was reported that during eye injection silicone was injected and now they see "floaters" with a bd syringe safety 3ml ll 22x1.The following information was provided by the initial reporter: it was reported by the patient that they received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".
 
Manufacturer Narrative
The following fields have been updated with additional information: b.5.Describe event or problem: it was reported that during eye injection silicone was injected and now they see "floaters" with a bd syringe safety 3ml ll 22x1.The following information was provided by the initial reporter: (1 of 3 complaints) it was reported by the patient that they received an injection in their eye and silicone was injected, which remains in their eye, and as a result is seeing "floaters".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 h3 other text : see h.10.
 
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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 Key9240118
MDR Text Key171979770
Report Number2243072-2019-02380
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,foreign,health profe
Type of Report Initial,Followup,Followup,Followup
Report Date 11/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/25/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date01/31/2024
Device Catalogue Number307862
Device Lot Number9014709
Date Manufacturer Received10/10/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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