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

Catalog Number 305210

Device Problem Volume Accuracy Problem (1675)

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

Event Date 09/03/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It has been reported that the syringe oral 3ml amber has been found experiencing 111 occurrences of scale marking issues before use.The following has been provided by the initial reporter: it was reported that ink was coming off of the syringe.It also felt like lubrication on the syringe our customer has indicated they have an additional 111 packages of cat #: 308-305210 from the affected lot #8263592.Original reported complaint: ink is coming off of the syringe.Feels like lubrication on the syringe.

Event Description

It has been reported that the syringe oral 3ml amber has been found experiencing 111 occurrences of scale marking issues before use.The following has been provided by the initial reporter: it was reported that ink was coming off of the syringe.It also felt like lubrication on the syringe.Our customer has indicated they have an additional 111 packages of cat #: 308-305210 from the affected lot #8263592.Original reported complaint: ink is coming off of the syringe.Feels like lubrication on the syringe.

Manufacturer Narrative

H.6.Investigation: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.No root cause can be determined as no samples were received.A device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.

• 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: 9083054
• MDR Text Key: 195299450
• Report Number: 1213809-2019-00942
• 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: 11/08/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305210
• Device Lot Number: 8263592
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other