MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC STOPCOCK; STOPCOCK, I.V. SET

Catalog Number 2C6218

Device Problem Break (1069)

Patient Problems Low Blood Pressure/ Hypotension (1914); Blood Loss (2597)

Event Date 12/19/2016

Event Type  Injury  

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Event Description

A three gang large bore stopcock manifold broke during use causing the patient¿s blood pressure to drop.It was reported that when a patient was repositioned during an unspecified infusion, the patient¿s blood pressure had dropped (not further specified).Upon assessing the patient¿s medications and lines, it was noted by the nurse that the manifold had snapped in half.The patient was treated with multiple unspecified vasopressors as intervention in order to regain the blood pressure (doses, frequencies and routes were not reported).No further information was provided regarding the patient¿s outcome from the event.No additional information is available.

Manufacturer Narrative

It was reported by the customer that the manifold is used as a substitute product (no further detail was provided) and that the product was too rigid.It was reported that the patient was being treated in the intensive care unit for an unspecified indication.The patient was receiving three vasoactive medications (norepinephrine at 20 mcg per minute, phenylephrine at 825 ¿mcs¿ per minute, and vasopressin at a set dose/rate [not further specified]).The customer stated the patient ¿may have¿ received emiuterone through the same access port (dose unspecified).The patient was on cvvh (continuous venous infusion where no other agents went through the port).While turning the patient, the manifold snapped in half and as a result, the patient was not receiving the vasopressors.There was an unspecified amount of blood loss from the patient.A new manifold (unspecified) was quickly primed and put in place.Subsequently, the patient was placed on unspecified ¿high dose¿ vasopressors (doses and frequencies were not reported).Medwatch uf/importer report # (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

Additional information: device evaluated by mfr?, evaluation codes, and additional mfr narrative.The device was received for evaluation.A visual inspection was performed and confirmed that one of the stopcocks broke off between the male luer and female luer.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The sample analysis verified the customer reported issue during the visual inspection.The cause of the event could not be determined.A nonconformance has been opened to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: STOPCOCK
• Type of Device: STOPCOCK, I.V. SET
• Manufacturer (Section D): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; haina san cristobal
• Manufacturer (Section G): BAXTER HEALTHCARE - DOMINICAN REPUBLIC; carretera sanchez km 18.5; parque industrial itabo, piisa; haina san cristobal ; DR
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6230312
• MDR Text Key: 64078307
• Report Number: 1416980-2016-19095
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130245
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/06/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 2C6218
• Device Lot Number: DR15L14042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/19/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/07/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/14/2015
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR