MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS SYRINGE ORAL 10ML AMBER; LIQUID MEDICATION DISPENSER

Catalog Number 305209

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Code Available (3191)

Event Date 01/01/2019

Event Type  malfunction  

Manufacturer Narrative

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.Device expiration date: unknown.Device manufacture date: unknown.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 a unspecified bd syringe had scale marking error.The following was reported, "material no.Unknown batch no.Unknown.It was reported that the syringes are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed."hi, in looking back, it does not appear that this report was submitted to you.I apologize for the delay.Please see the attached product feedback form from the hospital, pharmacy, regarding the neo med oral amber syringes 1, 3, 5, 10, 20 & 60ml, (mf# various), (lot# various).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.Upon completion of your investigation, please ensure that a copy of the qa report is sent to.Reference product feedback #(b)(4) in all follow-up communication.Thank you.".

Manufacturer Narrative

The additional information is as follows: b.3.Date of event: (b)(6) 2019, d.1.Medical device brand name: syringe oral 10ml amber, d.1 medical device type: kyw, d.2.Common device name: liquid medication dispenser, d.3.Medical device manufacturer: becton dickinson medical systems, d.4 medical device catalog #: 305209, d.4.Unique identifier (udi) #: (b)(4), g.2 manufacturing location: becton dickinson medical systems.

Event Description

It was reported that a unspecified bd syringe had scale marking error.The following was reported, "material no.Unknown batch no.Unknown it was reported that the syringes are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed." hi , in looking back, it does not appear that this report was submitted to you.I apologize for the delay.Please see the attached product feedback form from the hospital, pharmacy, regarding the neo med oral amber syringes 1, 3, 5, 10, 20 & 60ml , (mf# various), (lot# various).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.Upon completion of your investigation, please ensure that a copy of the qa report is sent to.Reference product feedback #15073 in all follow-up communication.Thank you.".

Manufacturer Narrative

Correction: b.5.Describe event or problem: it was reported that a syringe oral 10ml amber had scale marking error.The following was reported, material no.305209.Batch no.Unknown.It was reported that the syringes are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.In looking back, it does not appear that this report was submitted to you.I apologize for the delay.Please see the attached product feedback form from the hospital, pharmacy, regarding the neo med oral amber syringes 1, 3, 5, 10, 20 & 60ml , (mf# various), (lot# various).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.H.6.Investigation summary: no samples displaying the condition reported are available for examination.We were unable to fully investigate this incident, and no root cause can be determined as no samples were received.A device history record review could not be performed as lot number was unknown.

Event Description

It was reported that a syringe oral 10ml amber had scale marking error.The following was reported, material no.305209.Batch no.Unknown.It was reported that the syringes are difficult to accurately read once they are filled with liquid.The black markings are very difficult to accurately read which had led to incorrect doses of high alert medication being dispensed.In looking back, it does not appear that this report was submitted to you.I apologize for the delay.Please see the attached product feedback form from the hospital, pharmacy, regarding the neo med oral amber syringes 1, 3, 5, 10, 20 & 60ml , (mf# various), (lot# various).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.

• Brand Name: SYRINGE ORAL 10ML 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: 8459506
• MDR Text Key: 145530058
• Report Number: 2243072-2019-00584
• 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: foreign,other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 04/17/2019

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: 305209
• 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