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

Catalog Number 309597

Device Problem Connection Problem (2900)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/27/2024

Event Type  malfunction  

Event Description

It was reported that the bd integra syringe had a needle connectivity issue.The following information was provided by the initial reporter: external evaluation is required for takeda tw (b)(4) - gattex - needle - bent/ broken/damaged product: gattex bd plastic dosing syringe (1 ml) with needle attached (26g, 5/8 inch) bd syringe lot number(s): 2263232 takeda awareness date: 21feb2024.Complaint owner: (b)(6) ppd pqc intake received a call on (b)(6) 2024 at 11:47am: pharmacist called and stated that patient is taking gattex 5mg vial and reported that it is leaking, the needle is loose, and he is having difficulty with the syringes included within the kit.The caller advised this has been an ongoing issue so there is no specific date.The caller mentioned the vial was leaking and the needle was loose and came off in the patients hand.The caller also mentioned that the patient is having difficulty with the syringes that are included within the kit he is drawing in air with the syringes.The caller attempted to contact the patient who could not hold due to time, the caller mentioned if someone can call him back later.Rph was provided the number to medical information to call back at a later time due to the patient missing his dose for today.Kit and drug were both sealed.Rph will let patient know to hold on to defective vial and syringes and for the patient to send email with pictures, email was provided to the caller.Status: requesting external evaluation country of origin: united states sample / photo availability: no sample or photos were provided to takeda.Ae: ae unknown patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.

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.

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
• Type of Device: 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: 18955790
• MDR Text Key: 339322676
• Report Number: 1213809-2024-00173
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903095972
• UDI-Public: (01)30382903095972
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/09/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/21/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 309597
• Device Lot Number: 2263232
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/09/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1