MAUDE Adverse Event Report: BECTON DICKINSON SYR 3ML LL W/NDL SFTYGLD 23X1-1/2 RB TW; NEEDLE, HYPODERMIC, SINGLE LUMEN

Catalog Number	303326
Medical Device Problem Code	Difficult or Delayed Activation (2577)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/15/2024
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.The actual date of event is unknown.The date received by manufacturer was entered into the date of event field.
Event or Problem Description
Material# 303326 batch# 4010391 it was reported by customer that the needle itself is very flimsy and bends easily.The safety device is difficult to engage because that is also flimsy and bends the needle as you are engaging the safety device.Verbatim: rcc received a complaint via email.Email(s) attached it is the bd safetyglide 3ml syringe.Ref 303326.The needle itself is very flimsy and bends easily.The safety device is difficult to engage because that is also flimsy and bends the needle as you are engaging the safety device.Lot number - 4010391 customer response on august 05, 2024 this is being shipped today.They are different lot numbers but still same issue.Customer response on august 09, 2024 i didn't write down the lot number that i put in the box.You'll have to check that upon arrival.I can't guarantee the one i would give you off the shelf is the same.
Event or Problem Description
No additional information received material# 303326; batch# 4010391.It was reported by customer that the needle itself is very flimsy and bends easily.The safety device is difficult to engage because that is also flimsy and bends the needle as you are engaging the safety device.Verbatim: rcc received a complaint via email.Email(s) attached it is the bd safetyglide 3ml syringe.Ref 303326.The needle itself is very flimsy and bends easily.The safety device is difficult to engage because that is also flimsy and bends the needle as you are engaging the safety device.Lot number - 4010391.Customer response on august 05, 2024.This is being shipped today.They are different lot numbers but still same issue.Customer response on august 09, 2024.I didn't write down the lot number that i put in the box.You'll have to check that upon arrival.I can't guarantee the one i would give you off the shelf is the same.
Additional Manufacturer Narrative
(b)(4) follow up for device evaluation: it was reported the needle is flimsy, bends easily and the safety device is difficult to engage.To aid in the investigation, five samples in sealed packaging blisters from lot 3306576 were received for evaluation by our quality team.A visual inspection was performed, and no defects or imperfections were observed.Each sample was then tested by activating the safety mechanism.All the samples functioned with no issues.A device history record review was completed for provided material number 303326, lot 3306576.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.There were no related quality notifications.All processes and final inspections complied with specification requirements.To date, there have been no other similar events reported for this lot.Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed.

• Brand Name: SYR 3ML LL W/NDL SFTYGLD 23X1-1/2 RB TW
• 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: 19974621
• Report Number: 1911916-2024-00590
• Device Sequence Number: 7075691
• Product Code: FMI
• UDI-Device Identifier: 00382903033263
• UDI-Public: (01)00382903033263
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K951254
• 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): 08/19/2024

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: 303326
• Device Lot Number: 3306576
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/05/2024
• Supplement Date Received by Manufacturer: 08/19/2024
• Initial Report FDA Received Date: 08/13/2024
• Supplement Report FDA Received Date: 08/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/02/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown