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

Catalog Number	309597
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
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.
Event or Problem Description
Materials#: 309597 batch#: 2263232.It was reported that the bd syringe 1ml s/t w/ndl 26x5/8 rb was clogged/blocked.The following information was provided by the initial reporter: "for the last 2 days patient's 27 gauge needle has been coming off when he pushed plunger to administer medication." verbatim: rcc received a complaint via email.Email(s) attached.External evaluation is required for takeda tw pr# (b)(4) ¿ 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: 14 may 2024.Complaint owner: description: for the last 2 days patient's 27 gauge needle has been coming off when he pushed plunger to administer medication.Patient's husband insisted on troubleshooting issue and declined pharmacist.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: 14june2024.Biologics & plasma complaints senior specialist.Global product quality surveillance.Takeda pharmaceutical company limited.
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 for the last 2 days patient's 27 gauge needle has been coming off when he pushed plunger to administer medication.Verbatim: rcc received a complaint via email.Email(s) attached.External evaluation is required for takeda tw pr# (b)(4) ¿ 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: 14 may 2024.Complaint owner: xxxxxx xxxxx.Description: for the last 2 days patient's 27 gauge needle has been coming off when he pushed plunger to administer medication.Patient's husband insisted on troubleshooting issue and declined pharmacist.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: 14june2024.Biologics & plasma complaints senior specialist.Global product quality surveillance.Takeda pharmaceutical company limited.

• 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: 19506796
• Report Number: 1213809-2024-00362
• Device Sequence Number: 20696121
• 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): 06/25/2024

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: 05/14/2024
• Supplement Date Received by Manufacturer: 06/25/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 06/26/2024
• 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