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U.S. Department of Health and Human Services


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Catalog Number UNKNOWN
Device Problem Missing Information (4053)
Patient Problem Insufficient Information (4580)
Event Date 03/30/2021
Event Type  Injury  
Manufacturer Narrative
Device expiration date: unknown. The customer's address is unknown:  (b)(4) has been used as a default.   fda notified: the initial reporter also notified the fda on (date) via medwatch # mw5101698. Device manufacture date: unknown. Investigation summary: as no physical sample, material and/or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed. Based on the limited investigation results, a cause for the reported incident could not be determined. Examination of the product involved may provide clarification as to the cause for the reported failure. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends. Investigation conclusion: based on limited information available and after multiple unsuccessful attempts to obtain, the material number and batch number is unknown; reviews could not be performed and it was not possible to assess the rm documentation. No physical sample was provided by the customer. Capa is not required at this time.
Event Description
It was reported that the unspecified bd syringe was involved with a patient receiving expired product. The product defect resulted in a delay to the lay user patient being able to treat their underlying disease. The lay user/consumer experienced a worsening of their symptoms. The symptoms were not specified, and it was not mentioned whether medical intervention was administered. The following information was provided by the initial reporter: i received infusions of a medication at home every two weeks to keep a serious and potentially life-threatening disease under control. For that, i have a central venous catheter, which can be a source of blood infections if i use products that are not sterile. I have to push or infuse iv medications prior to that infusion in order to prevent side effects that would cause me (and have in the past caused me) to be hospitalized. One of those medications required a 1 ml luer lock syringe (slip tip may also work) because it is a high potency medication and my dose is 0345 ml, i also have serious and potentially life-threatening side effects if i receive too much of that iv medication. I have been told that, due to covid-19 1 ml syringes are being diverted for use in vaccination. I received 1 ml luer lock syringes in single-use packaging. The syringes that i was sent to by a specialty pharmacy were at least 10 years old and potentially up to 13 years old. And the packaging was visibly yellowed. Due to their age, the packaging did not have manufacturing or expiration dates. This means that they likely were no longer sterile and could have caused a blood infection (which could cause severe disability or death from sepsis and/or septic shock). Through colonization of my central line. Because i have used medical devices for such a long time. Unfortunately, most patients and home health nurses would not be aware of this and there was no way to tell from the packaging how old the syringes were because i did not have safe syringes to use. My infusion was delayed which caused the symptoms of my underlying disease to worsen. Additionally the specialty pharmacy then sent 1 ml slip tip syringes that were approximately 10 years old, based on the packaging (made by bd) after i refused to use those for the same reason and had further delay in my infusion, the company told me that they were unable to get 1 ml syringes, they were only able to send me 3 ml syringes. As a result, since 2021, i have not gotten an accurate dose of an iv pre medication, which is making me sick and potentially could result in hospitalization or death if i accidentally draw up too much of that medication. When i contacted my distributor to ask them whether the syringes were safe to use since i initially wasn't given another option by the specialty pharmacy, they would not talk to me or answer my question because i had not ordered the syringes directly from them. Instead they hung up on me twice after i asked if it was safe to use the syringes. Given that the specialty pharmacy thought it was acceptable to send these products to me, there was no way for me, as a consumer, to determine whether the syringes were safe to use.
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Type of DeviceSYRINGE
Manufacturer (Section D)
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
MDR Report Key12208137
MDR Text Key265891446
Report Number2243072-2021-01949
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 07/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/22/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNKNOWN
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received06/22/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 07/22/2021 Patient Sequence Number: 1