MAUDE Adverse Event Report: BECTON DICKINSON BD UNDISCLOSED SYRINGE/NEEDLE; NEEDLE, HYPODERMIC

Catalog Number UNKNOWN

Device Problem Break (1069)

Patient Problem Insufficient Information (4580)

Event Date 01/13/2024

Event Type  malfunction  

Event Description

It was reported that bd undisclosed syringe/needle- needle breaks.The following information was provided by the initial reporter: patient stated per pharmacist: "she reports the needle breaking off from the syringe upon injection.It has happened to her on more than one occasion.Maybe the angle of injection is bad or she is apply too much force.She is no longer using the needle/syringe provided in the kits.Instead, she is using a 1ml syringe and attaching a separate 27g needle.She says it works better for her.

Manufacturer Narrative

H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.B3.The date received by manufacturer has been used for this field.E1.Address information was not provided, therefore, xx was used as a place holder.In this mdr, bd franklin lakes, nj has been listed in sections d.3.And g.1.As the manufacturing site is unknown.

Manufacturer Narrative

The reported defect could not be refuted nor confirmed in the absence of a sample.The root cause cannot be determined for an unconfirmed defect.A complaint history review cannot be performed as no material and batch/lot number was provided.A device history review cannot be performed as no material and batch/lot number was provided.Based on limited information available after multiple unsuccessful attempts to obtain - unable to assess the rm documentation.

Event Description

Material#: unknown; lot#: unknown.It was reported by the customer reported that she reports the needle breaking off from the syringe upon injection.It has happened to her on more than one occasion.Maybe the angle of injection is bad or she is apply too much force.She is no longer using the needle/syringe provided in the kits.Instead, she is using a 1ml syringe and attaching a separate 27g needle.She says it works better for her.Verbatim: rcc received a complaint via email.Email(s) attached.Notification only (no investigation required) for pr# (b)(4).Tw (b)(4)¿ needle - bent / damaged / broken.Lot numbers: unknown, not obtained / reported via takeda follow ups.Takeda awareness date: 29dec2023.Patient stated per pharmacist: "she reports the needle breaking off from the syringe upon injection.It has happened to her on more than one occasion.Maybe the angle of injection is bad or she is apply too much force.She is no longer using the needle/syringe provided in the kits.Instead, she is using a 1ml syringe and attaching a separate 27g needle.She says it works better for her.Product: gattex.Country of origin: united states.Sample / photo availability: no sample or photos were provided to takeda.Ae: none.Patient identifiers available? (i.E.Gender, weight, ethnicity, etc.): patient identifiers will not be available for any investigation request.

• Brand Name: BD UNDISCLOSED SYRINGE/NEEDLE
• Type of Device: NEEDLE, HYPODERMIC
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18629238
• MDR Text Key: 334409798
• Report Number: 2243072-2024-00103
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: 505
• Type of Report: Initial,Followup
• Report Date: 02/15/2024

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
• Device Operator: Other
• Device Catalogue Number: UNKNOWN
• Device Lot Number: UNKNOWN
• Initial Date Manufacturer Received: 01/13/2024
• Initial Date FDA Received: 02/02/2024
• Supplement Dates Manufacturer Received: 02/15/2024
• Supplement Dates FDA Received: 02/20/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1