BARD DISPOZ-A-BAG LEG BAG UNK

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed with the FDA on 2017-04-12 for BARD DISPOZ-A-BAG LEG BAG UNK manufactured by Productos Para El Cuidado De La Salud -9611590.

Event Text Entries

[72786873] 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.
Patient Sequence No: 1, Text Type: N, H10


[72786874] It was reported that the urine leaked into the inlet tube. Subsequently, the urine would not flow into the bag.
Patient Sequence No: 1, Text Type: D, B5


[79161834] Received 1 used dizpoz-a-bag only. The reported event was unconfirmed, as the problem could not be reproduced. Visual inspection noted no obvious defects on the sample received. The sample was inspected and did not see any folds in the flutter valve that could have contributed to the reported issue. The sample was received with extension tubing. Per functional evaluation, the sample received was functionally tested, the extension tube is part of the sample received was connected to a new 16 fr. Catheter (is not part of the sample received) after the sample was tested passing water through of new 16 fr. Catheter, and noted the liquid flow toward the interior of the bags until is filled to its maximum capacity. During this test, did not note that the flow stopped. The flow was continuous. At last, the liquid of the leg bags was drained to the exterior of the bags and did not note any difficulty or problem to drain. Additionally the vinyl? S were cut to verify the embossed of the bags to be correct on the sample received and no problem noted on the embossed. During the test of the sample received in the assembly extension tubing to bag not was observed problem of the leak in the assembly. After that, the bag was cut checked the embossed on the flutter valve on the sample received. Reviewed the inlet tube of the bag where the flutter valve is sealed for any type of obstruction and no problem was found. Reviewed that the flutter valve was not bend or had any type of obstruction and no problem was found. Reviewed the embossed of the flutter valve, which is on the external part; therefore, the assembly is correct. Reviewed the embossed of the clear vinyl of the leg bag, which is on the internal part; therefore, the assembly is correct. Reviewed the peripheral seal, rotary seal of the bags and no problem was found. No problem could be noticed on the flutter valve on the sample received the device history record was reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "- position bag on leg with flutter valve at top. - attach catheter or extension tubing to top inlet. When wearing bag below knee, attach bard? Extension tubing (catalog no. 150615 or 4a4194). When using extension tubing, make sure to connect tube at least to the 3rd taper of the connector. -to empty dispoz-a-bag? , push green lever on flip-flo? Valve out and down. " (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.
Patient Sequence No: 1, Text Type: N, H10


[79161835] It was reported that the urine leaked into the inlet tube. Subsequently, the urine would not flow into the bag.
Patient Sequence No: 1, Text Type: D, B5


MAUDE Entry Details

Report Number1018233-2017-01757
MDR Report Key6488107
Date Received2017-04-12
Date of Report2017-06-01
Date Mfgr Received2017-05-08
Date Added to Maude2017-04-12
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Reporter OccupationOTHER CAREGIVERS
Health Professional3
Initial Report to FDA3
Report to FDA3
Event Location3
Manufacturer ContactAMY GRAVLEY
Manufacturer Street8195 INDUSTRIAL BLVD
Manufacturer CityCOVINGTON GA 30014
Manufacturer CountryUS
Manufacturer Postal30014
Manufacturer Phone7707846100
Manufacturer G1PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
Manufacturer StreetKM. 7 CARRETERA INTERNACIONAL
Manufacturer CityNOGALES, SONORA 85621
Manufacturer CountryMX
Manufacturer Postal Code85621
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameBARD DISPOZ-A-BAG LEG BAG
Generic NameLEG BAG
Product CodeFAQ
Date Received2017-04-12
Returned To Mfg2017-04-04
Catalog NumberUNK
Lot NumberUNK
Device AvailabilityR
Device AgeDA
Device Eval'ed by MfgrY
Device Sequence No1
Device Event Key0
ManufacturerPRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590
Manufacturer AddressKM. 7 CARRETERA INTERNACIONAL NOGALES, SONORA 85621 MX 85621


Patients

Patient NumberTreatmentOutcomeDate
10 2017-04-12

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