MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCKS

Catalog Number 394601

Device Problem Disconnection (1171)

Patient Problems Low Blood Pressure/ Hypotension (1914); Low Oxygen Saturation (2477); Loss Of Pulse (2562)

Event Date 06/12/2016

Event Type  Injury  

Manufacturer Narrative

(b)(6).There is no 510(k) for this device as it is manufactured outside the us and not sold in the us.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

The suspect device disconnected at the luer connection to central line.At the time, oliclinomel n7, g5 (500ml), potassium, cernevit, nutryelt was infusing through the line as well as morphine running continuously by pump syringe.The patient then started to feel "unwell." at disconnection, air entered the iv line(about 30cm) but not into the central line.Clinical consequences observed: blood pressure decreased significantly, oxygen saturation was at 84% and the patient had no pulse for 20 seconds.As a result, medical interventions were taken directly after stopcock detachment which include: restoration in continuity of the infusion line, blood volume expansion and oxygen therapy for the patient.

Manufacturer Narrative

Date received by manufacturer 6/15/2016.Pma / 510(k) #: k974083.

Manufacturer Narrative

Results: a sample is not available for evaluation.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 6007610.A manufacturing review revealed no issues with the manufacturing process, maintenance or calibrated instruments.Conclusion: without a sample, an absolute root cause for this incident cannot be determined as bd was not able to duplicate or confirm the customer¿s indicated failure mode.

• Brand Name: BD CONNECTA¿ STOPCOCKS
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer (Section G): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 5762419
• MDR Text Key: 48573028
• Report Number: 9610847-2016-00021
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K974083
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 07/18/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/30/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/31/2018
• Device Catalogue Number: 394601
• Device Lot Number: 6007610
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 06/15/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2016
• 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): Required Intervention