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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 TOOMEY IRRIGATION SYRINGE; TOOMEY SYRINGE

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 TOOMEY IRRIGATION SYRINGE; TOOMEY SYRINGE Back to Search Results
Catalog Number 0038460
Device Problems Loose or Intermittent Connection (1371); Device Inoperable (1663)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 03/16/2016
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Event Description
It was reported that dr.(b)(6) was using the toomey and tried to connect a device to the toomey as he has in the past, however, it was allegedly loose.The apparent loose state meant that the toomey could not be used as a suction device.The nurses tried several other toomeys but allege the same thing happened.The rep, (b)(4), also tried three different toomeys and found the same thing.The toomey syringe was allegedly being used during a turp procedure to suction out chips from the prostate.
 
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
Manufacturer Narrative
Received 3 unopened toomey syringes in the original unit packaging of the same lot.During the visual inspection no obvious defects were noted in the samples.Functional evaluation was performed, in order to verify the function of the samples the following task were performed: fill the syringe with 70cc water.Hold the syringe.During this test detected that the syringes did not hold the water.The plunger slipper through the barrel itself.Dimensional evaluation found the plunger tip out of specification in all samples.The reported event is confirmed as supplier related.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instruction for use states the following: "three syringe tips are intended for use as follows: integral toomey tip - resectoscope irrigation, catheter tip - for catheter irrigation, 1 luer adapter (for foley catheter inflation)." (b)(4).The information provided by bard represents all of the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard.
 
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Brand Name
TOOMEY IRRIGATION SYRINGE
Type of Device
TOOMEY SYRINGE
Manufacturer (Section D)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX  85621
Manufacturer (Section G)
PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
km. 7 carretera internacional
nogales, sonora 85621
MX   85621
Manufacturer Contact
janna parks
8195 industrial blvd
covington, GA 30014
7707846100
MDR Report Key5565679
MDR Text Key42949267
Report Number1018233-2016-00452
Device Sequence Number1
Product Code KYZ
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Type of Report Initial,Followup,Followup
Report Date 05/03/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/09/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date07/31/2020
Device Catalogue Number0038460
Device Lot NumberNGZF4488
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/06/2016
Is the Reporter a Health Professional? No
Date Manufacturer Received05/03/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured07/08/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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