MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PHASEAL¿ INJECTOR LUER LOCK N35C; INTRAVASCULAR ADMINISTRATION SET

Model Number	515004
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	09/13/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.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 or Problem Description
It was reported that the bd phaseal¿ injector luer lock n35c leaked liquid through the membrane into the air filter.The following information was provided by the initial reporter, translated from (b)(6) to english: "when the antibiotic has been mixed and the liquid is to be drawn into the syringe, and you adjust and spray some air back into the bottle, liquid leaks into the air filter part, ie the bubble is filled with antibiotics.This has happened repeatedly.".
Additional Manufacturer Narrative
H.6.Investigation: one photo received for investigation, upon visual inspection it can be confirmed that leaks are present in the filter of the protector, the filter appears oversaturated.Five retained samples from the same lot were evaluated, functional testing was completed, liquid inside the syringe could move to the vial and back to the syringe without issue.Lot number is unknown for injector,.Therefore lot history could not be performed, no retained samples could be analyzed.If the protector is used more than once, liquid may accumulate and oversaturate the filter.This oversaturation would create a pressure which prevented proper air release to the expansion chamber.The same effect may occur if liquid accumulated within the internal face of the vial rubber stopper, overpressure could then create a leak into the expansion chamber.
Event or Problem Description
It was reported that the bd phaseal¿ injector luer lock n35c leaked liquid through the membrane into the air filter.The following information was provided by the initial reporter, translated from swedish to english: "when the antibiotic has been mixed and the liquid is to be drawn into the syringe, and you adjust and spray some air back into the bottle, liquid leaks into the air filter part, ie the bubble is filled with antibiotics.This has happened repeatedly.".

• Brand Name: BD PHASEAL¿ INJECTOR LUER LOCK N35C
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer (Section G): BECTON DICKINSON, S.A.; camino de valdeolivia; s/n; san agustin de guadalix
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12658025
• Report Number: 3003152976-2021-00697
• Device Sequence Number: 4233282
• Product Code: ONB
• UDI-Device Identifier: 30382905150044
• UDI-Public: 30382905150044
• Combination Product (Y/N): N
• Initial Reporter Country: SW
• PMA/510(K) Number: K140591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/07/2021

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: Other
• Device Model Number: 515004
• Device Catalogue Number: 515004
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/01/2021
• Supplement Date Received by Manufacturer: 12/07/2021
• Initial Report FDA Received Date: 10/19/2021
• Supplement Report FDA Received Date: 12/29/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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