MAUDE Adverse Event Report: BECTON DICKINSON SYRINGE 50ML LL TIP 1ML; SYRINGE, PISTON

Catalog Number 309653

Device Problem Missing Information (4053)

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

Event Date 02/06/2024

Event Type  malfunction  

Manufacturer Narrative

(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.

Event Description

Material#: 30965 lot#3275057 it was reported by the customer that the bd 50ml syringe is missing a digit on its packaging.: bd 50ml syringe is missing a digit on its packaging.It states ref (b)(4) but is missing the 3 at the end.Lot#3275057.

Event Description

No additional information received.Material#: 30965, lot# 3275057.It was reported by the customer that the bd 50ml syringe is missing a digit on its packaging.Verbatim: bd 50ml syringe is missing a digit on its packaging.It states ref #30965 but is missing the 3 at the end.Lot#3275057.Follow up: hi bd alaris, this was noted by (b)(6) from bd alaris when she was on site at (b)(6) 2024.I believe (b)(6) has the product and she also took pictures of it.Yes, it was received in this condition.

Manufacturer Narrative

(b)(4) follow up.It was reported a digit was missing on the packaging.To aid in the investigation, one photo was provided for evaluation by our quality team.The photo shows a packaging blister top web with an sku number that is missing the last digit; the number shown is only '30965' and is missing the number '3'.The bottom of the linear barcode shows the sku number complete.No other information could be obtained from the photo.This defect could occur if there was a glitch in the printer.A device history record review was completed for provided material number 309653, lot 3275057.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.Verification of the printing process was performed, and the printing was correct.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed.

• Brand Name: SYRINGE 50ML LL TIP 1ML
• Type of Device: SYRINGE, PISTON
• 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: 18757218
• MDR Text Key: 336763756
• Report Number: 1911916-2024-00130
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 30382903096535
• UDI-Public: (01)30382903096535
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K110771
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/28/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2024
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 309653
• Device Lot Number: 3275057
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/28/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/02/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1