MAUDE Adverse Event Report: GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Model Number	42521E
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Hemorrhage/Blood Loss/Bleeding (1888)
Date of Event	07/15/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 gra 15dp ckv 3ss w/2 4w stpck dehp free experienced component separation, and leakage.The following information was provided by the initial reporter: standard bd smartsite gravity iv set have defective stopcocks that will not tighten.They are used as the standard iv srt oncold lines in the or.Despite tightening they will still become loose and cause potential harm to patient.On this specific event i had tightened the stopcocks prior to pushing induction medications.They appeared to be securely tightened.We had prepped the l arm hiding the iv site and tubing in the same arm we were placing a large bore micro-puncture catheter.While placing the line (needle in arm), we noticed that the iv was dripping well despite there being a tourniquet on the arm.We then moved the drape and noticed the stopcocks had disconnected and intravenous fluid and approximately 100cc of patient's blood were lost from the iv set disconnection.There are many other instances, most don't get put into our qms system.I don't have the particular lot number but as i said it happens too frequently to be a one time manufacturing issue.There is some element of design which prevents the stopcocks from tightening.
Event or Problem Description
It was reported that the gra 15dp ckv 3ss w/2 4w stpck dehp free experienced component separation, and leakage.The following information was provided by the initial reporter: standard bd smartsite gravity iv set have defective stopcocks that will not tighten.They are used as the standard iv srt oncold lines in the or.Despite tightening they will still become loose and cause potential harm to patient.On this specific event i had tightened the stopcocks prior to pushing induction medications.They appeared to be securely tightened.We had prepped the l arm hiding the iv site and tubing in the same arm we were placing a large bore micro-puncture catheter.While placing the line (needle in arm), we noticed that the iv was dripping well despite there being a tourniquet on the arm.We then moved the drape and noticed the stopcocks had disconnected and intravenous fluid and approximately 100cc of patient's blood were lost from the iv set disconnection.There are many other instances, most don't get put into our qms system.I don't have the particular lot number but as i said it happens too frequently to be a one time manufacturing issue.There is some element of design which prevents the stopcocks from tightening.
Additional Manufacturer Narrative
Correction: imdrf annex g grid g04123 stopcock.H6: investigation summary: as no physical sample, material and/or lot number was provided for evaluation by our quality engineer team, a complete investigation could not be performed.A device history review could not be completed as no batch number was provided.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 h10.

• Brand Name: GRA 15DP CKV 3SS W/2 4W STPCK DEHP FREE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12339021
• Report Number: 9616066-2021-51825
• Device Sequence Number: 4441791
• Product Code: FPA
• UDI-Device Identifier: 50885403274259
• UDI-Public: 50885403274259
• Combination Product (Y/N): N
• Initial Reporter State: CA
• 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): 08/26/2021

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: 42521E
• Device Catalogue Number: 42521E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/19/2021
• Supplement Date Received by Manufacturer: 08/26/2021
• Initial Report FDA Received Date: 08/18/2021
• Supplement Report FDA Received Date: 09/03/2021
• 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