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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD¿ SYRINGE
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BECTON DICKINSON UNSPECIFIED BD¿ SYRINGE Back to Search Results
Catalog Number UNKNOWN
Device Problem Patient-Device Incompatibility (2682)
Patient Problems Inflammation (1932); Pain (1994); Loss of Vision (2139); Reaction, Injection Site (2442)
Event Date 01/12/2018
Event Type  malfunction  
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.(b)(4).Medical device expiration date: unknown.Device evaluated by mfr: 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 the patient received an eylea injection with the unspecified bd¿ syringe in the right eye, but began experiencing "progressively worsening problems" later that evening, including watering, pain, and loss of vision in the injected eye.There was "continuing pain" and "complete loss of vision" in the right eye the following morning, which symptoms have reportedly "continued to this day".After an investigation, certain lots of eylea kits included unspecified bd¿ syringes that were lubricated with silicone, which was found to be the cause of "intraocular inflammation" and other adverse reactions in patients who received injections.The following information was provided by the initial reporter: my client received an eylea injection in his right eye at on (b)(6) 2018 - 4mg, lot# 8148200093, expiration date july 31, 2018.So far as we are aware, there were no complications or irregularities in the procedure itself.As instructed, the physician used the syringe provided and packaged with the eylea dosage.My client was to follow-up in four weeks.In the evening on (b)(6), my client began to experience progressively worsening problems, including watering and pain and loss of vision in the right eye.He woke the following morning with continuing pain and complete loss of vision in the eye that had been injected.This was the beginning of severe problems (including loss/deterioration of vision) that have continued to this day, as a result of the subject eylea injections.In this same time frame coinciding with my client's problems, there was a significantly increased incidence of intraocular inflammation (ioi) and associated issues following eylea injections (an incidence will above the expected incidence and well above the level risk as disclosed to the public, patients, and physicians).An investigation was conducted and determined that certain lots of eylea kits - including lot number 8148200093 - included syringes that were lubricated with silicone; and this was the cause and origin of the high incidence of adverse reactions and problems in patient receiving injections.
 
Manufacturer Narrative
H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.
 
Event Description
It was reported that the patient received an eylea injection with the unspecified bd¿ syringe in the right eye, but began experiencing "progressively worsening problems" later that evening, including watering, pain, and loss of vision in the injected eye.There was "continuing pain" and "complete loss of vision" in the right eye the following morning, which symptoms have reportedly "continued to this day".After an investigation, certain lots of eylea kits included unspecified bd¿ syringes that were lubricated with silicone, which was found to be the cause of "intraocular inflammation" and other adverse reactions in patients who received injections.The following information was provided by the initial reporter: my client received an eylea injection in his right eye at on (b)(6) 2018 - 4mg, lot# 8148200093, expiration date july 31, 2018.So far as we are aware, there were no complications or irregularities in the procedure itself.As instructed, the physician used the syringe provided and packaged with the eylea dosage.My client was to follow-up in four weeks.In the evening on (b)(6), my client began to experience progressively worsening problems, including watering and pain and loss of vision in the right eye.He woke the following morning with continuing pain and complete loss of vision in the eye that had been injected.This was the beginning of severe problems (including loss/deterioration of vision) that have continued to this day, as a result of the subject eylea injections.In this same time frame coinciding with my client's problems, there was a significantly increased incidence of intraocular inflammation (ioi) and associated issues following eylea injections (an incidence will above the expected incidence and well above the level risk as disclosed to the public, patients, and physicians).An investigation was conducted and determined that certain lots of eylea kits - including lot number 8148200093 - included syringes that were lubricated with silicone; and this was the cause and origin of the high incidence of adverse reactions and problems in patient receiving injections.
 
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Brand Name
UNSPECIFIED BD¿ SYRINGE
Type of Device
SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
MDR Report Key8540541
MDR Text Key142806944
Report Number2243072-2019-00766
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
UNKNOWN
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Type of Report Initial,Followup
Report Date 05/31/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/23/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Date Manufacturer Received04/08/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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