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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. CONNECTA WHT 360DEG TB 50CM; INFUSION DISPOSABLE
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BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. CONNECTA WHT 360DEG TB 50CM; INFUSION DISPOSABLE Back to Search Results
Catalog Number 394951
Device Problem Leak/Splash (1354)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/06/2020
Event Type  malfunction  
Manufacturer Narrative
A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
 
Event Description
It was reported that connecta wht 360deg tb 50cm injection port was loose.This was discovered before use.The following information was provided by the initial reporter: our customer was home with a patient and should connect the 3-way stopcock to the patient.She didn't force anything but the connector got loose, the connector closest to the patient.She didn't use the 3-way stopcock so no liquid has been in it.
 
Manufacturer Narrative
The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: (b)(6) 2020.H.6.Investigation: a device history record review was performed for provided lot number 9165860 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this incident, two picture samples and one physical sample were provided for evaluation by our quality engineer team.Through examination of the samples, the product was observed damaged.It was observed during the investigation that the tubing was damaged probably by a misassemble from station 7 of ka72 machine since during the manufacturing of the batch this issue was detected and corrected by the personnel.A quality alert was issued in response to this incident, in an attempt to increase the awareness of this potential defect.H3 other text : see h.10.
 
Event Description
It was reported that connecta wht 360deg tb 50cm injection port was loose.This was discovered before use.The following information was provided by the initial reporter: our customer was home with a patient and should connect the 3-way stopcock to the patient.She didn't force anything but the connector got loose, the connector closest to the patient.She didn't use the 3-way stopcock so no liquid has been in it.
 
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Brand Name
CONNECTA WHT 360DEG TB 50CM
Type of Device
INFUSION DISPOSABLE
Manufacturer (Section D)
BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.
periferico luis donaldo
colosio no. 579
nogales
MX 
MDR Report Key9898415
MDR Text Key195313283
Report Number9610847-2020-00112
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 05/26/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/30/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date05/31/2022
Device Catalogue Number394951
Device Lot Number9165860
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/14/2020
Date Manufacturer Received03/09/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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