Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
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
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK Back to Search Results
Catalog Number 394605
Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Patient Problems Laceration(s) (1946); Tissue Damage (2104)
Event Date 08/28/2019
Event Type  malfunction  
Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
 
Event Description
It has been reported that the bd connecta¿ stopcock has been found deformed during use.The following has been provided by the initial reporter: this patient is a child with agitation, the customer believes that due to product design problems, the water chestnut part caused skin scratches.
 
Manufacturer Narrative
Correction: received on 9/18/2019, one used unit and an opened empty package from catalog number 394605, lot number 8290710.Sent sample for decontamination.The following information has been updated: describe event or problem: it has been reported that one bd connecta¿ stopcock has been found deformed during use.The following has been provided by the initial reporter: this patient is a child with agitation, the customer believes that due to product design problems, the water chestnut part caused skin scratches.Medical device lot #: 8290710.Medical device expiration date: 2021-09-30.Device available for eval? yes.Returned to manufacturer on: 2019-09-18.Device returned to manufacturer: yes.Device manufacture date: 2018-11-09.
 
Event Description
It has been reported that one bd connecta¿ stopcock has been found deformed during use.The following has been provided by the initial reporter: this patient is a child with agitation, the customer believes that due to product design problems, the water chestnut part caused skin scratches.
 
Event Description
It has been reported that one bd connecta¿ stopcock has been found deformed during use.The following has been provided by the initial reporter: this patient is a child with agitation, the customer believes that due to product design problems, the water chestnut part caused skin scratches.
 
Manufacturer Narrative
H.6.Investigation summary: a device history review was conducted for lot number 8290710.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.Additionally, the returned device was inspected for burrs or other abnormalities that could have cause the observed abrasions on the patient, however the device was found to free of any such anomalies.Based on our review of the device, the root cause for this complaint could not be determined at the conclusion of our review.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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 Key9084624
MDR Text Key191272414
Report Number9610847-2019-00573
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,Followup
Report Date 10/25/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/18/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date09/30/2021
Device Catalogue Number394605
Device Lot Number8290710
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/18/2019
Date Manufacturer Received08/29/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-