MAUDE Adverse Event Report: BECTON DICKINSON UNSPECIFIED BD SYRINGE; PISTON SYRINGE

Catalog Number UNKNOWN

Device Problem Missing Information (4053)

Patient Problem Insufficient Information (4580)

Event Date 03/30/2021

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.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.The customer's address is unknown.Unknown, (b)(6) usa has been used as a default.Fda notified?: the initial reporter also notified the fda via medwatch #mw5101698.Device manufacture date: unknown.Investigation: 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.

Event Description

It was reported that an unspecified bd¿ syringe was missing label information.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 dirverted for use in vaccination.In i received 1 ml luer lock syringes in single-use packaging made by tyco healtchare.Tyco healthcare was dissolved/purchased by covidien in 2007 and then divested to cardinal health a few years ago.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 yelled.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 sucha long time.I was aware that tyco has not existed for a very 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 becase 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 cardinal health to ask them whether the syringes were safe to use since 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 consumer to determine whether the syringes manufactured by tyco healthcare were safe to use.Only have lot number because of how old these are.".

• Brand Name: UNSPECIFIED BD SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12207240
• MDR Text Key: 272986911
• Report Number: 2243072-2021-01943
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/07/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/21/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/22/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1