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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK Back to Search Results
Catalog Number 394995
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 12/23/2019
Event Type  malfunction  
Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that during use of the bd connecta¿ stopcock there was an issue with leakage.The following information was provided by the initial reporter: the user of the product, took some blood tests on a patient and she started by attaching a new three-way crane bd connecta to the cvk.Right after unwrapping it.When she flush with the saline solution, it splashes liquid outside.She checked all connections, and tried again and the same incident happened with liquid.After a careful check she saw that the tube at the end closest to the patient had a cracked to 2 mm.This time it was fortunately it was just nacl and it did not back blood.The user means that when they give antibody drug they will fill the crane with drugs without flushing before, and that the drug will flow slowly and it would have taken a long time before any leak was detected on the damage.
 
Event Description
It was reported that during use of the bd connecta¿ stopcock there was an issue with leakage.The following information was provided by the initial reporter: the user of the product, took some blood tests on a patient and she started by attaching a new three-way crane bd connecta to the cvk.Right after unwrapping it.When she flush with the saline solution, it splashes liquid outside.She checked all connections, and tried again and the same incident happened with liquid.After a careful check she saw that the tube at the end closest to the patient had a cracked to 2 mm.This time it was fortunately it was just nacl and it did not back blood.The user means that when they give antibody drug they will fill the crane with drugs without flushing before, and that the drug will flow slowly and it would have taken a long time before any leak was detected on the damage.
 
Manufacturer Narrative
H.6.Investigation summary: a device history record review was performed for provided lot number 9193084 and the review did not reveal any detected abnormalities during the production process that could have contributed to this reported incident.To further investigate this issue, one picture sample was returned for evaluation by our quality team.Through examination of the picture, leakage was observed; however, the picture did not show signs of why the leakage occurred or if damage was present on the product.Based on the limited investigation results, an exact cause for this incident could not be determined.At this time, further action has not been determined necessary.Our quality team will continue to monitor the production process for any emerging trends.
 
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Brand Name
BD CONNECTA¿ STOPCOCK
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 
MDR Report Key9564203
MDR Text Key195275634
Report Number9610847-2019-00806
Device Sequence Number1
Product Code FMG
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 01/30/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date06/30/2022
Device Catalogue Number394995
Device Lot Number9193084
Date Manufacturer Received12/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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