MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA Q-SYTES WHT; STOPCOCK

Catalog Number 394501

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)

Patient Problems Emotional Changes (1831); Low Oxygen Saturation (2477); Missed Dose (2561)

Event Date 04/24/2020

Event Type  Injury  

Manufacturer Narrative

Multiple lot numbers were provided and it is not known which is associated with the defective product.The information for each lot number is as follows: medical device lot #: 9246765, medical device expiration date: 08-31-2022, device manufacture date: 09-27-2019, medical device lot #: 9116509, medical device expiration date: 03-31-2022, device manufacture date: 05-06-2019.Investigation summary: a device history record review was performed for the two possible provided lot numbers; 9246765 and 9116509.The review did not reveal any detected quality issues during the production process of either lot number that could have contributed to this reported incident and all inspections were found to be within specification.To aid in the investigation of this issue, three picture samples were received for evaluation by our quality engineer team.Through examination of the pictures, luer-lok damage was observed.The potential causes for luer-lok detachment include incorrect assembly within the manufacturing facility and excess silicone presence.It is also possible that the detachment resulted from incorrect use.Based on the evaluation of the picture samples alone, the exact cause could not be determined.In response to this incident, a quality alert was issued to all related manufacturing personnel, in an attempt to increase awareness for this potential defect.Investigation conclusion: bd was able to confirm the customer¿s indicated failure mode in the photos provided.The potential causes for luer lock detachment is a wrong assembly (in station 03) or the silicon presence on port a (as consequence of excess of silicone in station 06).It is recommended send unused samples to perform a deeper investigation.The maintenance records were reviewed and during the manufacture of this both lots no adjustments were performed that contributes to this failure mode.Quality records have been consulted for tracking and trending purposes but issues like this are not detected which means pretty low occurrence.During the manufacturing were taken samples and tested by collar nut removal force lsl = 35n.Material 394501 & batch 9116509.160 samples were taken and tested per collar nut removal force all the samples passed above the specification.Material 394501 & batch 9246765.148 samples were taken and tested per collar nut removal force all the samples passed above the specification we will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Process (b)(4) were reviewed and there are proper controls in place to detect product malfunctions.Root cause description: based on investigation results to date, probable root causes can be associated to station 03 (wrong assembly of luer) or incorrect customer use.Rationale: no capa based on an evaluation of severity and frequency it was determined that no corrective action is required at this time.

Event Description

It was reported that an unspecified number of connecta q-sytes wht experienced device damage/deformation while still considered operable.Product defect was noted during use.The product defect resulted in a serious injury in the form of a missed dosage which caused agitation, respiratory distress, and desaturation.It has not been specified whether medical intervention was applied as a result.The following information was provided by the initial reporter: sedated intubated patient with a left jugular three-way central line.Patient was agitated and desaturated at time of injury.Valve positioned on the distal ktc line according to the service protocol, sedation line of the intubated patient.Fluid-soaked valve cover.After examination, liquid corresponding to propofol.Luer lock ring of the valve broken making the device unsealable.The patient does not receive the prescribed dose of sedation, resulting in agitation, respiratory distress and desaturation.

• Brand Name: CONNECTA Q-SYTES WHT
• Type of Device: STOPCOCK
• 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: 10071370
• MDR Text Key: 198896883
• Report Number: 9610847-2020-00155
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 394501
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/30/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other