MAUDE Adverse Event Report: BECTON DICKINSON NEEDLE 27X1/2 RB; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	305109
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/05/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Initial mdr submission.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Event or Problem Description
Material# 305109.Batch# 3179204.It was reported by customer that they self-administering medication iv, client reported medication leaked at connection point between needle tip and syringe despite being securely attached.Noted to have approximately 0.8 ml of medication left in syringe.Dose should be 1.4 ml.Verbatim: rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id):(b)(4).Date of incident (yyyy-mm-dd): (b)(6) 2024.Site name/location: xxx.Level of harm: minimal harm.Ahs optional report to cmdsnet (health canada): incident details: while self-administering medication iv, client reported medication leaked at connection point between needle tip and syringe despite being securely attached.Noted to have approximately 0.8 ml of medication left in syringe.Dose should be 1.4 ml.Impact of incident: client received lower dose than ordered.Who was affected? patient.Device information.Device name/description: needle hypodermic precision glide regular bevel 27 gauge x 0.5 inch.Manufacturer: becton dickinson canada inc.Manufacturer code/model: 305109.Serial or lot number: (b)(6).Device expiry date (yyyy-mm-dd unknown.Supplier: medline canada corporation.Supplier catalogue number: 308-305109.Was the device retained? no.
Additional Manufacturer Narrative
(b)(4) follow up a device history record review was completed by our quality engineer team for provided material number 305109 and lot number 3179204.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.Should you again experience any problems with our product we would appreciate the opportunity to conduct a thorough analysis.There are quality controls currently in place to detect this type of defect during the production process.Further action has not been determined necessary at this time.
Event or Problem Description
No additional information received material# 305109 batch# 3179204 it was reported by customer that they self-administering medication iv, client reported medication leaked at connection point between needle tip and syringe despite being securely attached.Noted to have approximately 0.8 ml of medication left in syringe.Dose should be 1.4 ml.Rcc received a complaint via email.Email(s) attached.Ahs mdip reference number (id): (b)(4) date of incident (yyyy-mm-dd): on (b)(6) 2024 site name/location: xxx level of harm: minimal harm ahs optional report to cmdsnet (health canada): incident details: while self-administering medication iv, client reported medication leaked at connection point between needle tip and syringe despite being securely attached.Noted to have approximately 0.8 ml of medication left in syringe.Dose should be 1.4 ml.Impact of incident: client received lower dose than ordered.Who was affected? patient device information device name/description: needle hypodermic precision glide regular bevel 27 gauge x 0.5 inch manufacturer: becton dickinson canada inc manufacturer code/model: 305109 serial or lot number: 3179204 device expiry date (yyyy-mm-dd unknown supplier: (b)(4) supplier catalogue number: 308-305109 was the device retained? no.

• Brand Name: NEEDLE 27X1/2 RB
• 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 (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 19527130
• Report Number: 1911916-2024-00423
• Device Sequence Number: 18068409
• Product Code: FMI
• UDI-Device Identifier: 30382903051091
• UDI-Public: (01)30382903051091
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K021475
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/19/2024

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: Health Professional
• Device Catalogue Number: 305109
• Device Lot Number: 3179204
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/10/2024
• Supplement Date Received by Manufacturer: 06/19/2024
• Initial Report FDA Received Date: 06/13/2024
• Supplement Report FDA Received Date: 06/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/28/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown