MAUDE Adverse Event Report: BECTON DICKINSON BD GEM V/NV 20D 0.2 FLTR; INTRAVASCULAR ADMINISTRATION SET

Model Number	2232-0007
Medical Device Problem Code	Complete Blockage (1094)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/27/2022
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 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, (b)(4).Device expiration date: unknown.Initial reporter state: the customer's state was determined to be (b)(6) based on the area code portion of the provided phone #.Device manufacture date: unknown.Investigation summary: no product or photo was returned by the customer.It was reported by customer that the lipid tubing was able to be primed but would not infuse could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because a lot number and material number was not provided by the customer.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
Event or Problem Description
It was reported that the unspecified bd infusion set experienced blockage.The following information was provided by the initial reporter: we had a lipid tubing that was able to be primed but would not infuse.
Additional Manufacturer Narrative
The following fields were updated due to additional information: b5: describe event or problem: it was reported that the bd gem v/nv 20d 0.2 fltr experienced blockage.The following information was provided by the initial reporter: we had a lipid tubing that was able to be primed but would not infuse.D1: medical device brand name: bd gem v/nv 20d 0.2 fltr.D4: udi # (b)(4).D10: device available for eval yes, d10: returned to manufacturer on: 05-aug-2022 g.5.Pma / 510(k)#: k931173.Investigation summary: 2 used samples (model#2232-0007 ) were returned for quality investigation by the customer.It was reported by customer that the lipid tubing was able to be primed but would not infuse was not observed.Prior to functional testing the sets were visually examined for defects and abnormalities.No defects or abnormalities were observed.The set was loaded into an alaris pump and an infusion run with a 1ml/hr rate was started.The infusion was stopped after approximately 17 hours.There was no "occlusion" prompt on the pump.The customer complaint could not be replicated.A device history record review could not be performed on model # 2232-0007 because a lot number was not provided by the customer.The root cause of this complaint could not be definitively determined because the issue could not be replicated.
Event or Problem Description
It was reported that the bd gem v/nv 20d 0.2 fltr experienced blockage.The following information was provided by the initial reporter: we had a lipid tubing that was able to be primed but would not infuse.

• Brand Name: BD GEM V/NV 20D 0.2 FLTR
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15127322
• Report Number: 2243072-2022-01014
• Device Sequence Number: 5619931
• Product Code: FPA
• UDI-Device Identifier: 50885403463967
• UDI-Public: 50885403463967
• Combination Product (Y/N): N
• Initial Reporter State: DE
• Initial Reporter Country: US
• PMA/510(K) Number: K931173
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/06/2022

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: Other
• Device Model Number: 2232-0007
• Device Catalogue Number: 2232-0007
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/28/2022
• Supplement Date Received by Manufacturer: 09/06/2022
• Initial Report FDA Received Date: 07/28/2022
• Supplement Report FDA Received Date: 09/23/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown