MAUDE Adverse Event Report: BECTON DICKINSON NORMAL SALINE 3ML FILL IN 3ML SYRINGE; SALINE FLUSH SYRINGE

Model Number	306507
Medical Device Problem Code	Short Fill (1575)
Health Effect - Clinical Code	Underdose (2542)
Date of Event	01/15/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this device may have been manufactured.A 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.No lot # provided.Device expiration date: unknown.Device manufacture date: unknown.
Event or Problem Description
It was reported that while using 0.9% normal saline 3ml fill in 3ml syringe, nursing staff became concerned the full volume was not being delivered when used in the hospital's bd alaris pump.When nursing staff tested the syringes, they found only 4ml was delivered when 6ml that was programmed into the bd alaris pump.No injury or deterioration in patient condition was reported related to underdosing.
Event or Problem Description
It was reported that while using 0.9% normal saline 3ml fill in 3ml syringe, nursing staff became concerned the full volume was not being delivered when used in the hospital's bd alaris pump.When nursing staff tested the syringes, they found only 4ml was delivered when 6ml that was programmed into the bd alaris pump.No injury or deterioration in patient condition was reported related to underdosing.
Additional Manufacturer Narrative
The following field has been updated with corrected information: g.4.Date received by manufacturer: (b)(6) 2020.
Additional Manufacturer Narrative
H.6.Investigation summary as no physical sample, picture sample, or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.No dhr review can be carried out as lot number is unknown.Based on the limited investigation results, a cause for the reported incident could not be determined.Complaints received for this device and reported condition will continue to be tracked and trended.Our quality team regularly reviews the collected data for identification of emerging trends.H3 other text : see section h.10.
Event or Problem Description
It was reported that while using 0.9% normal saline 3ml fill in 3ml syringe, nursing staff became concerned the full volume was not being delivered when used in the hospital's bd alaris pump.When nursing staff tested the syringes, they found only 4ml was delivered when 6ml that was programmed into the bd alaris pump.No injury or deterioration in patient condition was reported related to underdosing.

• Brand Name: NORMAL SALINE 3ML FILL IN 3ML SYRINGE
• Common Device Name: SALINE FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 9673050
• Report Number: 2243072-2020-00148
• Device Sequence Number: 13567445
• Product Code: FOZ
• UDI-Device Identifier: 30382903065074
• UDI-Public: 30382903065074
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: K011982
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 306507
• Device Catalogue Number: 306507
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 02/15/2020
• Supplement Date Received by Manufacturer: 01/15/2020; 01/15/2020
• Initial Report FDA Received Date: 02/05/2020
• Supplement Report FDA Received Date: 02/11/2020; 02/26/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention