MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 3ML AMBER; LIQUID MEDICATION DISPENSER

Catalog Number 305210

Device Problems Device Markings/Labelling Problem (2911); Illegible Information (4050)

Patient Problem No Patient Involvement (2645)

Event Date 10/24/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).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 the syringe oral 3ml amber experienced 4 cases of no label or missing label information, and an instance of label or packaging smeared/print permanency which were noted prior to use.The following information was provided by the initial reporter: on inspection of a recent delivery, 4 boxes had missing lot numbers on the external label (the individual bags were labelled) and 1 box had a label that was damaged and unreadable.

Event Description

It was reported that the syringe oral 3ml amber experienced 4 cases of no label or missing label information, and an instance of label or packaging smeared/print permanency which were noted prior to use.The following information was provided by the initial reporter: on inspection of a recent delivery, 4 boxes has missing lot numbers on the external label (the individual bags were labelled) and 1 box had a label that was damaged and unreadable.

Manufacturer Narrative

This complaint has been identified as a duplicate of mfr report #: 1213809-2019-01122, therefore this mdr should be disregarded.

• Brand Name: SYRINGE ORAL 3ML AMBER
• Type of Device: LIQUID MEDICATION DISPENSER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 9297553
• MDR Text Key: 194190392
• Report Number: 1213809-2019-01123
• 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: 12/06/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/08/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305210
• Device Lot Number: 9024703
• Date Manufacturer Received: 10/24/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other