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 Code	Needle Stick/Puncture (2462)
Date of Event	09/22/2024
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 failure.It was reported by the customer that the safety cover did not clip over needle and cover needle after injecting.Verbatim: rcc received a complaint via email.(b)(4).Product problem report: product information: product code: 305781.Product description: syringe & needle 3cc 25g x 5/8in & safety eclipse bx/50.Lot/serial #: (b)(6).Expiry date: 2028-12-31.Problem information: cite customer complaint# (b)(4).Incident date: 22-09-2024.The safety cover did not clip over needle and cover needle after injecting.
Event or Problem Description
Material: 305759; batch#: 3360142.It was reported by the customer that the safety cover did not clip over needle and cover needle after injecting.Verbatim: rcc received a complaint via email.Email(s) attached.(b)(4).Product problem report; product information; product code: 305781; product description: syringe & needle 3cc 25g x 5/8in & safety eclipse bx/50 ; lot/serial #: (b)(6); expiry date: 2028-12-31.Problem information **cite customer complaint#(b)(4)** incident date: 22-09-2024 the safety cover did not clip over needle and cover needle after injecting.Additional info: 1.Kindly provide the batch/lot number of the product.Provided batch number #3360142 is not match with provided material number#305781.2.Describe any patient harm, injury, complication or negative outcome that occurred as a result of the event.Staff member received a needle poke to thumb with contaminated needle.3.Kindly confirm any physical sample or photo if available for investigation? if yes, please provide the address of the facility for us to ship the return label? the contaminated needle was disposed of immediately in sharps container.We know if this is to occur again the needle will be kept so that it can be shipped for further investigation.Please see the attached picture of the same batch of needles.I am not sure where to access the batch number so i thought it might be easy to send you a pic as i see there is a qr code on the product that might provide you with more information.
Additional Manufacturer Narrative
Our quality engineer inspected the photo submitted for evaluation.The reported issue of safety mechanism failure was not confirmed upon inspection of the photo.However, bd cannot confirm the cause of the failure to our manufacturing process since no physical sample was returned.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 batch meets our manufacturing specification requirements.

• 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; suzhou industrial park; singapore 21502 1; CH 215021
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20509627
• Report Number: 2243072-2024-01066
• Device Sequence Number: 12742629
• Product Code: FMI
• UDI-Device Identifier: 00382903057597
• UDI-Public: (01)00382903057597(11)240101(17)281231(10)3360142
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• 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): 10/28/2024

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: 3360142
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/27/2024
• Supplement Date Received by Manufacturer: 10/28/2024
• Initial Report FDA Received Date: 10/22/2024
• Supplement Report FDA Received Date: 10/28/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/01/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown