MAUDE Adverse Event Report: BECTON DICKINSON 112 IN 15 DROP IV ADMINISTRATION SET; INTRAVASCULAR ADMINISTRATION SET

Model Number	MX9128
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/17/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd 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 in and (b)(4) fda registration number has been used for the manufacture report number.Medical device expiration date: unknown.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that a 112 in 15 drop iv administration set had flow issues during use.The following was reported by the initial reporter: "it was reported that when injecting propofol into the smartsite port the drug went up into the iv bag vs to the patient.Verbatim: dr.Xxxxxx had an incident today in which he was injecting propofol in the smarsite port and the drug went up into the iv bag vs to the patient.He has a video on his phone but would not go through for us to see.No adverse event was noted.A new tubing was hung which worked.".
Event or Problem Description
It was reported that a 112 in 15 drop iv administration set had flow issues during use.The following was reported by the initial reporter: "it was reported that when injecting propofol into the smartsite port the drug went up into the iv bag vs to the patient.Verbatim: dr.Xxxxxx had an incident today in which he was injecting propofol in the smarsite port and the drug went up into the iv bag vs to the patient.He has a video on his phone but would not go through for us to see.No adverse event was noted.A new tubing was hung which worked.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 3/29/2021.H.6.Investigation: one sample (model #mx9128) was returned from the customer.It was reported that when injecting propofol into the smartsite port the drug went up into the iv bag vs to the patient.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was connected to a saline bag and successfully primed.Each smartsite on the set was connected to a 10 ml syringe and attempted to be flushed with at least 10 ml of a methylene blue/water mixture.Each smartsite was able to be flushed, and no back flow was observed.No methylene blue was observed traveling into the iv bag.The failure was unable to be replicated, and the complaint could not be verified.A device history record review could not be performed on model mx9128 because a lot number was not provided by the customer.A root cause was unable to be determined because the failure was unable to be replicated.

• Brand Name: 112 IN 15 DROP IV ADMINISTRATION SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• MDR Report Key: 11492039
• Report Number: 2243072-2021-00797
• Device Sequence Number: 14194192
• Product Code: FPA
• UDI-Device Identifier: 50885403237629
• UDI-Public: 50885403237629
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K051499
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other,use
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/13/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: MX9128
• Device Catalogue Number: MX9128
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/29/2021
• Initial Date Received by Manufacturer: 02/17/2021
• Supplement Date Received by Manufacturer: 04/13/2021
• Initial Report FDA Received Date: 03/16/2021
• Supplement Report FDA Received Date: 04/20/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1