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	05/06/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Material# 309597 batch# 2263232.It was reported that the bd integra leaked.The following information was provided by the initial reporter: an external evaluation is required for two complaint defect types from one reporter: pr# (b)(4) - leaking.Pr# (b)(4) - primary packaging / container difficult to open.Bd syringe: plastic dosing syringe (1 ml) with needle attached (26g, 5/8 inch).Bd syringe lot numbers: 2263232.Takeda awareness date: 30 apr 2024.The patient stated that the needle came off yesterday when giving the gattex and he had to use another vial, so he will be short one vial this month.The patient stated that he is always short one vial of diluent.No additional information provided.After following up with patient, while on the call.Customer claimed that the issue was with leaking.Dosing syringe separated upon use.Causing the medication to leak out onto patient's leg.An additional complaint was reported.The patient is claiming that the dosing syringes caps are difficult to open / remove.Patient struggles at this cap removal.The cap takes a lot of pressure to remove.Caps can fly across the room sometimes; due to the amount of pressure and force it takes to open them.Vial lot# 03880853 kit lot# av23223aa.Product: gattex.Country of origin: united states sample / photo availability: no photos provided.Ae: no ae reported patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.No further details provided.
Additional Manufacturer Narrative
B.3.The date received by manufacturer has been used for this field.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.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.

• 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: 19459911
• Report Number: 1213809-2024-00338
• Device Sequence Number: 6812796
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: (01)30382903095972
• Combination Product (Y/N): N
• Initial Reporter State: PA
• 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
• Report Date (Section B): 05/08/2024

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: 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: 05/06/2024
• Initial Report FDA Received Date: 06/04/2024
• 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