MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 26X3/8 IB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305110
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/15/2023
Type of Reportable Event	Malfunction
Event or Problem Description
Material#: 305110 batch#: unknown.It was reported by customer that caller reported past event of [unable to push plunger to insert insulin ].Verbatim: rcc received a complaint via email.Email(s) attached.¿ caller reported past event of [unable to push plunger to insert insulin ] ¿ with how many syringes/needles did the caller experience the issue? - [2] ¿ did all issues occur on the same day? ¿ no.Issues occurred: [10/15/23].¿ was the syringe/needle reused? - no.¿ product with issue - bd 26 g, 3/8" needle, pn 305110.¿ is product available for return to bd? ¿ no.¿ product lot # - unavailable.¿ did issue cause any injury? - no.¿ how did the caller resolve the issue? ¿ [caller reports she changed needle & was able to load catridge.].
Additional Manufacturer Narrative
Pr (b)(4): initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Patient problem code: f26 ¿ no health consequences or impact.Device problem code: a140901 - complete blockage.
Additional Manufacturer Narrative
Pr 9284827 follow up mdr for correction.It has been determined that this mdr was submitted in error.The reported event was determined to be not reportable to the fda.
Event or Problem Description
No additional information.

• Brand Name: NEEDLE 26X3/8 IB
• Common Device Name: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD MEDICAL (BD WEST) MEDICAL SURGICAL; 1852 10th avenue; columbus NE 68601
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18282621
• Report Number: 1911916-2023-00875
• Device Sequence Number: 12272886
• Product Code: FMI
• UDI-Device Identifier: 30382903051107
• UDI-Public: (01)30382903051107
• Combination Product (Y/N): N
• Initial Reporter State: AK
• Initial Reporter Country: US
• PMA/510(K) Number: K021475
• 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): 12/07/2023

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: Health Professional
• Device Catalogue Number: 305110
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2023
• Supplement Date Received by Manufacturer: 11/20/2023
• Initial Report FDA Received Date: 12/07/2023
• Supplement Report FDA Received Date: 12/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Female