MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD INTEGRA; PISTON SYRINGE

Catalog Number	309597
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/13/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that the bd integra leaked.The following information was provided by the initial reporter: "nurse educator reported that patient reported that upon initial attempt to mix medication, the diluent syringe top was open, drops of diluent were observed at the tip of the needle, and diluent was missing from the prefilled syringe.Nurse educator reported that patient reported the compromised syringe was discarded and a new prefilled syringe was used." external evaluation is required for takeda tw pr# (b)(4) ¿ defective component product: gattex bd plastic dosing syringe (1 ml) with needle attached (26g, 5/8 inch).Bd syringe lot number(s): 2263811.Takeda awareness date: 22 jan 2024.Complaint owner: (b)(6).Description: nurse educator reported that patient reported that upon initial attempt to mix medication, the diluent syringe top was open, drops of diluent were observed at the tip of the needle, and diluent was missing from the prefilled syringe.Nurse educator reported that patient reported the compromised syringe was discarded and a new prefilled syringe was used.Status: requesting external evaluation.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.No additional information provided.Inv due by: 26mar2024.Additional information provided on 02/26/2024: 1.Can you provide an event date? unknown.2.Please confirm the exact location of leakage/damage.Upon initial attempt to mix medication, the diluent syringe top was open, drops of diluent were observed at the tip of the needle and diluent was missing from the prefilled syringe.3.Please confirm a product is still operable or not? no ¿ syringe was discarded and not used.4.Please confirm whether any visible damage has been observed with the product.Syringe was received open.5.Was the product received in this condition? yes.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Additional Manufacturer Narrative
(b)(4): follow up mdr for device evaluation.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.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.We would be very interested in examining product that does not meet your expectations and our quality standards.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.Examination of the product involved may provide clarification as to the cause for the reported failure.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h10 manufacture narrative.

• Brand Name: BD INTEGRA
• 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: 18846982
• Report Number: 1213809-2024-00149
• Device Sequence Number: 7702388
• 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: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/08/2024

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: 2263811
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/13/2024
• Supplement Date Received by Manufacturer: 04/08/2024
• Initial Report FDA Received Date: 03/06/2024
• Supplement Report FDA Received Date: 04/09/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Labeled for Single Use? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown