MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE 1ML S/T W/NDL 26X5/8 RB; PISTON SYRINGE

Catalog Number	309597
Medical Device Problem Code	Separation Problem (4043)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/16/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Materials#: 309597, batch#: 2263232.It was reported that the bd syringe 1ml s/t w/ndl 26x5/8 rb had a syringe needle connectivity issue.The following information was provided by the initial reporter: verbatim: rcc received a complaint via email.Email(s) attached.Notification only for (b)(4) ¿ needle - blunt/dull.Bd syringe: plastic dosing syringe (1 ml) with needle attached (26g, 5/8 inch).Bd syringe lot number(s): 2263232.Takeda awareness date: (b)(6) 2024.Patient reports issues with injection syringe and getting full dose from vial.Needles are dull and come off syringe when trying to inject medication.Needles blow off and medication leaks out causing patient to reattach needle and attempt to inject dose again.Product: gattex.Country of origin: united states.Sample / photo availability: no sample or photos were provided to takeda.Ae: no ae reported.Patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.
Additional Manufacturer Narrative
Since no samples displaying the reported condition were received a potential root cause could not be defined and corrective actions are not necessary.A physical sample is required for a more thorough evaluation and potential root cause determination.
Event or Problem Description
Materials#: 309597.Batch#: 2263232.It was reported by the customer that needles are dull and come off syringe when trying to inject medication.Needles blow off and medication leaks out causing patient to reattach needle and attempt to inject dose again.Verbatim: rcc received a complaint via email.Notification only for pr# 4308226 ¿ needle - blunt/dull.Bd syringe: plastic dosing syringe (1 ml) with needle attached (26g, 5/8 inch).Bd syringe lot number(s): 2263232.Takeda awareness date: 16 may 2024.Patient reports issues with injection syringe and getting full dose from vial.Needles are dull and come off syringe when trying to inject medication.Needles blow off and medication leaks out causing patient to reattach needle and attempt to inject dose again.Product: gattex.Country of origin: united states.Sample / photo availability: no sample or photos were provided to takeda.Ae: no ae reported.Patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.

• Brand Name: BD SYRINGE 1ML S/T W/NDL 26X5/8 RB
• Common Device Name: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19724775
• Report Number: 1213809-2024-00446
• Device Sequence Number: 15505658
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: (01)30382903095972
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: K110771
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 309597
• Device Lot Number: 2263232
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/19/2024
• Supplement Date Received by Manufacturer: 07/18/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 07/19/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown