MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE ORAL¿ 5ML AMBER; LIQUID MEDICATION DISPENSER

Catalog Number 305208

Device Problem Device Markings/Labelling Problem (2911)

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

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.

Event Description

It was reported unspecified bd oral syringes¿ are difficult to accurately read once they are filled with liquid.Verbatim: the concern: these syringes are difficult to accurately read once they are filled with liquid.Several staff have reported that once a fluid is drawn up into the syringe, the black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.This is a general concern about the products usability and therefore not lot specific.

Event Description

It was reported bd syringe oral¿ 5ml amber are difficult to accurately read once they are filled with liquid.Verbatim: the concern: these syringes are difficult to accurately read once they are filled with liquid.Several staff have reported that once a fluid is drawn up into the syringe, the black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.This is a general concern about the products usability and therefore not lot specific.

Manufacturer Narrative

The following fields have been updated with additional information: b.3.Date of event: (b)(6) 2019, d.1.Medical device brand name: bd syringe oral¿ 5ml amber, d.1 medical device type: kyw, d.2.Common device name: liquid medication dispenser, d.3.Medical device manufacturer: becton dickinson medical systems ¿ canaan, ct / 06018, d.4 medical device catalog #: 305208, d.4.Unique identifier (udi) #: (b)(4), g.4.Date received by manufacturer: becton dickinson medical systems ¿ canaan, ct / 06018.H.6.Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident.A device history record review could not be performed as lot number was unknown.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored monthly.Our business team regularly reviews the collected data for identification of emerging trends.Root cause description: no root cause can be determined as no samples were received rationale: no capa is required.

• Brand Name: BD SYRINGE ORAL¿ 5ML 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: 8460877
• MDR Text Key: 145401719
• Report Number: 2243072-2019-00589
• Device Sequence Number: 1
• Product Code: KYW
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 04/04/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/28/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 305208
• Device Lot Number: UNKNOWN
• Date Manufacturer Received: 03/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other