MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD¿ ORAL DISPENSING SYRINGE 3 ML; ORAL SYRINGE

Catalog Number 305220

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/08/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bags for the bd¿ oral dispensing syringe 3 ml had no lot number identification on them.

Manufacturer Narrative

H.6.Investigation: two photos and two sealed bags containing 3ml oral syringe product were received and evaluated.The samples were confirmed to be from p/n 305220, but unknown batch #.No batch # was printed on the labels of the two bags.Potential root cause for the missing batch # defect is likely associated with the label printer during the packaging process.However, batch # is required for investigation and more precise root cause determination.Batch # is required to make corrective actions determination.Due to unknown batch#, it is not known when the batch was manufactured and whether the root cause condition still exists.Current production was evaluated and batch # is printed on the labels without issues.No corrective actions are necessary at this time based on the available information.A dhr could not be performed due to unknown lot#.

Event Description

It was reported that bags for the bd¿ oral dispensing syringe 3 ml had no lot number identification on them.

• Brand Name: BD¿ ORAL DISPENSING SYRINGE 3 ML
• Type of Device: ORAL SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8156205
• MDR Text Key: 130324763
• Report Number: 1213809-2018-00900
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,other
• Type of Report: Initial,Followup
• Report Date: 03/12/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/12/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305220
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 11/27/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other