MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE INTEGRA 3ML W/NDL 25X1 RB; SYRINGE, ANTISTICK

Catalog Number 305270

Device Problem Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/16/2023

Event Type  malfunction  

Manufacturer Narrative

Device problem code: a0202 - defective component patient problem code: f24 - insufficient information (b)(4).: 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 Description

Material #: 305270 batch#: 1168669 it was reported by customer that two separate needles out of same box of 100 were damaged, she ended up losing the vaccine out of both.The first one, the spring in the barrel came out.The second one she thinks had a crack somewhere, when she tried to use, the vaccine spilled out.Verbatim: rcc received a complaint via email.Email(s) attached.Two separate needles out of same box of 100 were damaged, she ended up losing the vaccine out of both.The first one, the spring in the barrel came out.The second one she thinks had a crack somewhere, when she tried to use, the vaccine spilled out.

Manufacturer Narrative

Two photos of 3ml integra syringe with 25x1¿ needle material 305270 were received and evaluated.The first photo shows two loose syringes one with a needle shielded and the other unshielded.The unshielded syringe has the plunger rod fully depressed, and the needle is not visible in the photo.The second photo shows a syringe with a shielded needle.The plunger rod has been drawn back, positioning the stopper between the bd print on the side of the syringe.It was observed the cutter had punctured through the stopper, yet the needle had not retracted.This indicates that a premature retraction occurred which was non-conforming per product specification.Potential root cause for the premature retraction defect is associated with the assembly process.A device history record review was completed for provided lot number 1168669 showing no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

Event Description

Material #: 305270 batch#: 1168669.It was reported by customer that two separate needles out of same box of 100 were damaged, she ended up losing the vaccine out of both.The first one, the spring in the barrel came out.The second one she thinks had a crack somewhere, when she tried to use, the vaccine spilled out.Verbatim: rcc received a complaint via email.Email(s) attached.Two separate needles out of same box of 100 were damaged, she ended up losing the vaccine out of both.The first one, the spring in the barrel came out.The second one she thinks had a crack somewhere, when she tried to use, the vaccine spilled out.

• Brand Name: SYRINGE INTEGRA 3ML W/NDL 25X1 RB
• Type of Device: SYRINGE, ANTISTICK
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18290751
• MDR Text Key: 330043062
• Report Number: 1213809-2023-01419
• Device Sequence Number: 1
• Product Code: MEG
• UDI-Device Identifier: 30382903052708
• UDI-Public: (01)30382903052708
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/25/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 305270
• Device Lot Number: 1168669
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/25/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/17/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1