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

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.

• Brand Name: BARDIA LATEX-FREE PISTON IRRIGATION SYRINGE, 60ML, INDIVIDUALLY SEALED
• Type of Device: IRRIGATION 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 Key: 5973130
• MDR Text Key: 55467375
• Report Number: 1018233-2016-01285
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: PRE-AMEND
• Number of Events Reported: 1
• 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 Received: 09/23/2016
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 802065
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/31/2016
• 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 Sequence Number: 1
• Patient Outcome(s): Hospitalization; Life Threatening; Required Intervention