MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD Q-SYTE VIAL ACCESS ADAPTER; INTRAVASCULAR ADMINISTRATION SET

Model Number	385108
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Skin Discoloration (2074)
Date of Event	01/03/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.Initial reporter facility: the user facility address is not available, the corporate headquarters information was used instead.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It has been reported that the bd q-syte vial access adapter has been found experiencing leakage during use.The following has been provided by the initial reporter: material no: 385108 batch no: unknown.It was reported that when the patient spikes the vial, sometimes the stopper will get a slit which has resulted in remoudulin to leak.Event description states: patient reports that when she spiked her vials sometimes the stopper will get a slit and remodulin will leak out (dates unknown).Patient also reports currently experiencing red marks on the bridge of her nose and along the creases by her mouth.Indication: pulmonary arterial hypertension (pah).No additional adverse events or side effects were mentioned by patient due to product issue.Lot and expiration date are unknown.Unknown if patient still has product on hand.Medwatch report# mw5091522 was filed in response to this event.

• Brand Name: BD Q-SYTE VIAL ACCESS ADAPTER
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales ; MX
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9622029
• Report Number: 9610847-2020-00012
• Device Sequence Number: 1865937
• Product Code: FPA
• UDI-Device Identifier: 30382903851080
• UDI-Public: 30382903851080
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Distributor
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/06/2020

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: Lay User/Patient
• Device Model Number: 385108
• Device Catalogue Number: 385108
• 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: 01/03/2020
• Supplement Date Received by Manufacturer: 01/03/2020
• Initial Report FDA Received Date: 01/23/2020
• Supplement Report FDA Received Date: 01/29/2020
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Female