MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 18X1-1/2 BLUNT FILL; NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE

Catalog Number 305180

Device Problems Break (1069); Fracture (1260)

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

Event Date 10/24/2023

Event Type  malfunction  

Manufacturer Narrative

(b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a040101 ¿ fracture.Patient problem code: f26 ¿ no health consequences or impact.

Event Description

Materials#: 305180; batch#: 3145002.It was reported by the customer that ¿needle device failure x 2 of same stock number.¿ needle broken.Verbatim: good afternoon.Yesterday, we had a safety event reported for bd item # 305180 (bd blunt fill needle 18 g x 1 1/2 in.).Let¿s identify this as (b)(4), as a reference number.The needle has been discarded.Based on the information provided below, could you start a product quality report? (b)(4): reported date: 10/24/2023; event date: (b)(6) 2023; item number: 305180; lot number: 3145002; item retained in defect depot?: no; picture: yes; patient harm: none; area: interventional radiology (acb).Event details: ¿needle device failure x 2 of same stock number¿.

Manufacturer Narrative

Pr (b)(4).Follow up mdr for correction (event not reportable) additional information from the customer states that there was no broken needle as was initially reported in the initial mdr.The initial mdr was submitted in error.If we become aware of information that changes this decision, an new supplemental mdr will be filed.

Event Description

Additional information from customer: the needle bent when used to puncture the medication x 2 materials#: 305180 batch#: 3145002 it was reported by the customer that ¿needle device failure x 2 of same stock number.¿ verbatim: good afternoon.Yesterday, we had a safety event reported for bd item # 305180 (bd blunt fill needle 18 g x 1 1/2 in.).Let¿s identify this as bd 252, as a reference number.The needle has been discarded.Based on the information provided below, could you start a product quality report? bd 252: reported date: 10/24/2023; event date: 10/24/2023; item number: 305180; lot number: 3145002; item retained in defect depot?: no; picture: yes, attached; patient harm: none; area: interventional radiology (acb) event details: ¿needle device failure x 2 of same stock number¿.

• Brand Name: NEEDLE 18X1-1/2 BLUNT FILL
• Type of Device: NEEDLE, ASPIRATION AND INJECTION, DISPOSABLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MDS DCHU; 75 north fairway drive; vernon hills IL 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18033214
• MDR Text Key: 327045839
• Report Number: 1911916-2023-00810
• Device Sequence Number: 1
• Product Code: GAA
• UDI-Device Identifier: 30382903051800
• UDI-Public: (01)30382903051800
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: NA
• 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: 11/01/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305180
• Device Lot Number: 3145002
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/25/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1