MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS BD SYRINGE ORAL 1ML AMBER

Catalog Number 305207

Device Problem Device Markings/Labelling Problem (2911)

Patient Problem No Code Available (3191)

Event Date 01/09/2019

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) 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 an unspecified bd oral syringe¿ is difficult to accurately read once 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

Investigation summary: 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.No root cause can be determined as no samples were received.

Event Description

It was reported an bd syringe oral¿ 1ml amber is difficult to accurately read once 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 an bd syringe oral¿ 1ml amber is difficult to accurately read once 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 that has been received: medical device brand name: bd syringe oral¿ 1ml amber.Medical device manufacturer: becton dickinson medical systems ¿ canaan, ct / 06018.Medical device catalog #: 305207.Unique identifier (udi) #: (b)(4).Manufacturing location: becton dickinson medical systems ¿ canaan, ct / 06018.Pma / 510(k)#: exempt.

• Brand Name: BD SYRINGE ORAL 1ML AMBER
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; route 7 and grace way; canaan CT 06018
• MDR Report Key: 8460876
• MDR Text Key: 141186083
• Report Number: 2243072-2019-00590
• Device Sequence Number: 1
• Product Code: FMF
• 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: 305207
• 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