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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDIA LATEX-FREE PISTON IRRIGATION SYRINGE, 60ML, INDIVIDUALLY SEALED

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PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDIA LATEX-FREE PISTON IRRIGATION SYRINGE, 60ML, INDIVIDUALLY SEALED Back to Search Results
Catalog Number 802065
Device Problems Device Contamination With Biological Material (2908); Device Disinfection Or Sterilization Issue (2909)
Patient Problems Bacterial Infection (1735); Cyst(s) (1800); Diarrhea (1811); Fever (1858); Renal Failure (2041); Sepsis (2067); Vomiting (2144)
Event Type  Injury  
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, as a result of using the device, the patient allegedly was hospitalized with an infection in the blood stream that resulted in renal failure, fever, vomiting, and sepsis. The patient allegedly used the irrigation syringe to flush out his bladder. It was later reported that on or around (b)(6), the patient started feeling bad, could not keep food down, had a fever and diarrhea. On (b)(6), the patient had a fever and was admitted to the hospital on (b)(6) with salmonella, an intestinal infection (c-dif), an abdominal cyst and sepsis. The patient was in the hospital for 9 days. It was reported that the patient was irrigating his bladder with a new syringe every other day; however, in the past, the patient would sometimes reuse a syringe to irrigate his bladder and sterilize it with very hot water and alcohol in between uses. The patient uses saline water to irrigate his bladder.
 
Manufacturer Narrative
The device was not returned for evaluation. The lot number is unknown; therefore, the device history record could not be reviewed. The instructions for use state the following: "single use only. Terile unless package is opened or damaged. Do not use if package is opened or damaged. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations. " (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. The device was not returned.
 
Event Description
It was reported that as a result of using the device, the patient allegedly was hospitalized with an infection in the blood stream that resulted in renal failure, fever, vomiting, and sepsis. The patient allegedly used the irrigation syringe to flush out his bladder. The complainant stated that the doctor informed her that "her son would have died had they not gotten him to the hospital when they did". It was later reported that on or around (b)(6), the patient allegedly started feeling bad, could not keep food down, had a fever, and diarrhea. On (b)(6), the patient had a fever. On (b)(6) the patient was admitted to the hospital with salmonella, an intestinal infection (c-dif), an abdominal cyst, and sepsis. The patient was allegedly in the hospital for 9 days. Prior to, and during this timeframe, the patient was allegedly irrigating his bladder with a new syringe every other day. However, in the past, the complainant stated that the patient would sometimes reuse a syringe to irrigate his bladder, and that the syringe was sterilized with very hot water and alcohol in between the two uses. The patient allegedly uses saline water to irrigate his bladder.
 
Manufacturer Narrative
The device was not returned for evaluation. The lot number is unknown; however, three lot numbers were reported by the complainant (ngzd2121, ngzs0189 and ngze2323), that may have been associated with the reported event. The device history records were reviewed and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: "single use only; sterile unless package is opened or damaged. Do not use if package is opened or damaged; after use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations. " (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. The device was not returned.
 
Event Description
It was reported that as a result of using the device, the patient allegedly was hospitalized with an infection in the blood stream that resulted in renal failure, fever, vomiting, and sepsis. The patient allegedly used the irrigation syringe to flush out his bladder. The complainant stated that the doctor informed her that "her son would have died had they not gotten him to the hospital when they did". It was later reported that on or around (b)(6), the patient allegedly started feeling bad, could not keep food down, had a fever, and diarrhea. On (b)(6), the patient had a fever. On (b)(6) the patient was admitted to the hospital with salmonella, an intestinal infection (c-dif), an abdominal cyst, and sepsis. The patient was allegedly in the hospital for 9 days. Prior to, and during this timeframe, the patient was allegedly irrigating his bladder with a new syringe every other day. However, in the past, the complainant stated that the patient would sometimes reuse a syringe to irrigate his bladder, and that the syringe was sterilized with very hot water and alcohol in between the two uses. The patient allegedly uses saline water to irrigate his bladder.
 
Manufacturer Narrative
The device was not returned for evaluation. The lot number is unknown; however, three lot numbers were reported by the complainant (ngzd2121(expiry: 04/30/2020. Mfg. Date: 04/30/2015), ngzs0189(expiry: 06/30/2020. Mfg. Date: 06/25/2015), and ngze2323 (expiry: 05/31/2020 mfg. Date: 06/09/2015)), that may have been associated with the reported event. Because the lot number that was involved in the complaint is unknown, the manufacturing date and expiry date fields will be left blank. The device history records were reviewed for all lots submitted, and found nothing that could have caused or contributed to the reported event. The instructions for use state the following: " single use only. Sterile unless package is opened or damaged. Do not use if package is opened or damaged. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable laws and regulations. " (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.
 
Event Description
It was reported that as a result of using the device, the patient allegedly was hospitalized with an infection in the blood stream that resulted in renal failure, fever, vomiting, and sepsis. The patient allegedly used the irrigation syringe to flush out his bladder. The complainant stated that the doctor informed her that "her son would have died had they not gotten him to the hospital when they did". It was later reported that on or around (b)(6), the patient allegedly started feeling bad, could not keep food down, had a fever, and diarrhea. On (b)(6), the patient had a fever. On (b)(6) the patient was admitted to the hospital with salmonella, an intestinal infection (c-dif), an abdominal cyst, and sepsis. The patient was allegedly in the hospital for 9 days. Prior to, and during this timeframe, the patient was allegedly irrigating his bladder with a new syringe every other day. However, in the past, the complainant stated that the patient would sometimes reuse a syringe to irrigate his bladder, and that the syringe was sterilized with very hot water and alcohol in between the two uses. The patient allegedly uses saline water to irrigate his bladder.
 
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Brand NameBARDIA LATEX-FREE PISTON IRRIGATION SYRINGE, 60ML, INDIVIDUALLY SEALED
Type of DeviceIRRIGATION 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 Key5973130
MDR Text Key55467375
Report Number1018233-2016-01285
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
PRE-AMEND
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,other
Reporter Occupation Patient Family Member or Friend
Type of Report Initial,Followup,Followup,Followup
Report Date 10/31/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/23/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number802065
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/31/2016
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/23/2016 Patient Sequence Number: 1
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