MAUDE Adverse Event Report: BECTON DICKINSON BD NEEDLE ECLIPSE 25X1-1/2 RB; SYRINGE

Catalog Number	305767
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported the bd needle eclipse 25x1-1/2 rb needle was clogged / blocked the following information was provided by the initial reporter: it was reported by customer that when injecting a patient's foot/heel needle (25g x 1.5 inch) would not inject medication (depo medrol and lidocaine).She attempted to readjust the needle and pull the plunger back several times, but medication would not deliver.Needle withdrawn intact.New needle applied and injection given.Resistance still presents with injection, but able to complete injection.Both needles from the same lot#1274891 bd eclipse.Verbatim: rcc received a complaint via email.Email(s) attached.Account name: (b)(6) hospital.Gpoid: h004458.Coid: a1610.Contract number: 687.Manufacturer: bd medical.Dear vendor, please review and provide a response to the product quality issue reported.Please contact the facility directly for details, sample collection and resolution.When the investigation has completed, please provide healthtrust with a copy of the final letter in order to close out the ticket in the healthtrust database.I will follow up with you for a status update in a couple of weeks.Facility contact:(b)(6).Department: materials management.Email: (b)(6).Product description: needle safety 25ga 1.5in orange metal hypodermic regular bevel bd eclipse sterile latex free disposable origin of the issue: nursing.Detail: injecting a patient's foot/heel when needle (25g x 1.5 inch) would not inject medication (depo medrol and lidocaine).She attempted to readjust the needle and pull the plunger back several times, but medication would not deliver.Needle withdrawn intact.New needle applied and injection given.Resistance still present with injection, but able to complete injection.Both needles from the same lot#1274891 bd eclipse.Number of occurrences: 1.0.Sample available: true.
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
Material#: 305767 , batch number#: 1274891.It was reported by customer that when injecting a patient's foot/heel needle (25g x 1.5 inch) would not inject medication (depo medrol and lidocaine).She attempted to readjust the needle and pull the plunger back several times, but medication would not deliver.Needle withdrawn intact.New needle applied and injection given.Resistance still presents with injection, but able to complete injection.Both needles from the same lot#1274891 bd eclipse.Verbatim#: rcc received a complaint via email.Email(s) attached.Please review and provide a response to the product quality issue reported.Please contact the facility directly for details, sample collection and resolution.When the investigation has completed, please provide healthtrust with a copy of the final letter in order to close out the ticket in the healthtrust database.I will follow up with you for a status update in a couple of weeks.Product catalog number: 305767.Product description: needle safety 25ga 1.5in orange metal hypodermic regular bevel bd eclipse sterile latex free disposable.Origin of the issue: nursing.Detail: injecting a patient's foot/heel when needle (25g x 1.5 inch) would not inject medication (depo medrol and lidocaine).She attempted to readjust the needle and pull the plunger back several times, but medication would not deliver.Needle withdrawn intact.New needle applied and injection given.Resistance still present with injection, but able to complete injection.Both needles from the same lot#1274891 bd eclipse.Number of occurrences: 1.0.Sample available: true.Lot number: 1274891 bd eclipse.Reply: · what is the date of event? 02-12-2024.· please share the material & lot number.Part #305767, lot#1274891.· describe any patient harm, injury, complication or negative outcome that occurred because of the event.None.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Current control there is a visual inspection on clogged needle at the qa outgoing inspection and visual inspection on clogged needle at the assembly in-process inspection.Actual root cause could not be determined as sample returned pass the visual inspection on clogged needle.

• Brand Name: BD NEEDLE ECLIPSE 25X1-1/2 RB
• Common Device Name: SYRINGE
• 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: 18941303
• Report Number: 2243072-2024-00307
• Device Sequence Number: 8381178
• Product Code: FMI
• UDI-Device Identifier: 30382903057673
• UDI-Public: (01)30382903057673
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 04/01/2024

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 Expiration Date: 09/30/2026
• Device Catalogue Number: 305767
• Device Lot Number: 1274891
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/27/2024
• Supplement Date Received by Manufacturer: 04/01/2024
• Initial Report FDA Received Date: 03/20/2024
• Supplement Report FDA Received Date: 04/01/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown