MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X5/8; HYPODERMIC SINGLE LUMEN NEEDLE

Catalog Number	305759
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Codes	Needle Stick/Puncture (2462); No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/06/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd needle eclipse 25x5/8 safety mechanism failed.It was reported by customer that they are having some safety issues with our bd needles.On multiple occasions the pink safety shield has popped off and also when we are screwing it on to the vials sometimes it breaks off.This happened to me personally before and yesterday it happened to one of our other lvns who actually had a needle stick incident.This is really dangerous working with our pediatric patients because sometimes they have fast hands too and i would hate for one of them to be poked verbatim: rcc received a complaint via email.Email(s) attached.Item: 305759.Quantity affected: 5 bx.Lot number: 4023388.Po : (b)(4).Are any samples available for return? yes.Reported issue: we are having some safety issues with our bd needles.On multiple occasions the pink safety shield has popped off and also when we are screwing it on to the vials sometimes it breaks off.This happened to me personally before and yesterday it happened to one of our other lvns who actually had a needle stick incident.This is really dangerous working with our pediatric patients because sometimes they have fast hands too and i would hate for one of them to be poked.Customer disposition request: credit.Customer contact information: xxxx.
Additional Manufacturer Narrative
Our quality engineer inspected the 200 representative samples submitted for evaluation.The reported issue of safety mechanism failure was not confirmed upon inspection of the samples.Analysis of the samples showed no damages or defects.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this lot meets our manufacturing specification requirements.The root cause could not be determined as the defect was not replicated.
Event or Problem Description
Material # 305759; batch # 4023388.It was reported by customer that they are having some safety issues with our bd needles.On multiple occasions the pink safety shield has popped off and also when we are screwing it on to the vials sometimes it breaks off.This happened to me personally before and yesterday it happened to one of our other lvns who actually had a needle stick incident.This is really dangerous working with our pediatric patients because sometimes they have fast hands too and i would hate for one of them to be poked verbatim: rcc received a complaint via email.Email(s) attached.Item: 305759; quantity affected: (b)(4); serial/lot number: (b)(6); po: (b)(4).Are any samples available for return? yes.Reported issue: we are having some safety issues with our bd needles.On multiple occasions the pink safety shield has popped off and also when we are screwing it on to the vials sometimes it breaks off.This happened to me personally before and yesterday it happened to one of our other lvns who actually had a needle stick incident.This is really dangerous working with our pediatric patients because sometimes they have fast hands too and i would hate for one of them to be poked.Customer disposition request: credit.

• Brand Name: BD NEEDLE ECLIPSE 25X5/8
• Common Device Name: HYPODERMIC SINGLE LUMEN NEEDLE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20371077
• Report Number: 2243072-2024-01015
• Device Sequence Number: 17080170
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597(11)240219(17)290131(10)4023388
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K010188
• 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): 10/21/2024

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: 305759
• Device Lot Number: 4023388
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/06/2024
• Supplement Date Received by Manufacturer: 10/21/2024
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 10/21/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/19/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown