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

Catalog Number	309597
Medical Device Problem Code	Volume Accuracy Problem (1675)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/07/2023
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
It was reported that the bd integra syringes had a scale marking issue.The following information was provided by the initial reporter: "patient reported he did not get the same syringes he has been receiving.He stated the outer package is the same but the syringes did not have markings and they are thinner syringes." rcc received a complaint via email.Email(s) attached.External evaluation is required for takeda tw pr# 3905272 ¿ defective component product: gattex bd plastic dosing syringe (1 ml) with needle attached (26g, 5/8 inch) bd syringe lot number(s): 2263232.Takeda awareness date: 07 nov 2023.Patient reported he did not get the same syringes he has been receiving.He stated the outer package is the same but the syringes did not have markings and they are thinner syringes.Sample / photo availability: sample was not provided to takeda.No photos provided.Ae: n/a patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.
Event or Problem Description
Material#: 309597 lot#: 2263232.It was reported by the customer reported that patient reported he did not get the same syringes he has been receiving.He stated the outer package is the same but the syringes did not have markings and they are thinner syringes.Verbatim: rcc received a complaint via email.Email(s) attached.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): 2263232.Takeda awareness date: (b)(6) 2023.Patient reported he did not get the same syringes he has been receiving.He stated the outer package is the same but the syringes did not have markings and they are thinner syringes.Sample / photo availability: sample was not provided to takeda.No photos provided.Ae: n/a.Patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.
Additional Manufacturer Narrative
Pr (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: 18480475
• Report Number: 1213809-2023-01525
• Device Sequence Number: 15054810
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/23/2024

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: Other
• 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: 12/14/2023
• Supplement Date Received by Manufacturer: 01/23/2024
• Initial Report FDA Received Date: 01/09/2024
• Supplement Report FDA Received Date: 01/25/2024
• 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): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown