MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 FEMALE CATH KIT, WITH VINYL GLOVES, SWABS, LUBRICANT AND TOWEL, SOFT, 8 FR.; FEMALE CATHETER KIT

Catalog Number 0035720

Device Problem Kinked (1339)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 02/12/2017

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.The device was not returned.

Event Description

It was reported that the catheter kinked during specimen collection.

Manufacturer Narrative

The device was not returned for evaluation.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: "1.- open package and remove plastic wallet.2.- open plastic wallet and don gloves.3.- pull catheter out of the tube to desire length.Lay tube on sterile field.4.- open lubricant and lubricate catheter.5.- open swab packet.Cleanse vaginal area.6.- proceed with catheterization.7.- pull catheter out of top: tighten cover and depress blue spout.8.- fill out label, place on centrifuge tube.Send to lab in normal manner.Important: 1.- use plastic wallet as sterile field.2.- pull catheter out of centrifuge tube to the proper length immediately after donning gloves.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly." (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 the catheter kinked during specimen collection.The catheter kinked approximately 1 cm from the tip of the catheter upon insertion.As a result, no urine drained from the catheter and the patient allegedly experienced pain and self-limited bleeding, due to the kink in the catheter.

Manufacturer Narrative

The device was not returned for evaluation.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: "1.- open package and remove plastic wallet.2.- open plastic wallet and don gloves.3.- pull catheter out of the tube to desire length.Lay tube on sterile field.4.- open lubricant and lubricate catheter.5.- open swab packet.Cleanse vaginal area.6.- proceed with catheterization.7.- pull catheter out of top: tighten cover and depress blue spout.8.- fill out label, place on centrifuge tube.Send to lab in normal manner.Important: 1.- use plastic wallet as sterile field.2.- pull catheter out of centrifuge tube to the proper length immediately after donning gloves.Note: if urine does not flow freely into the tube, the cap may need to be loosened slightly." (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 the catheter kinked during specimen collection.The catheter kinked approximately 1 cm from the tip of the catheter upon insertion.As a result, no urine drained from the catheter and the patient allegedly experienced pain and self-limited bleeding, due to the kink in the catheter.The registered nurse inserted the catheter to perform a straight cath, which was inserted without difficulty, but no urine was obtained.When pulling back on the catheter to remove it, the catheter coiled in the urethra, became stuck, and was difficult to pull out.Per palpitation, the catheter was felt to be bent.The physician was then called, who was able to gently remove the catheter.The catheter came out in one piece without a break.It was found it was bent one inch from the tip.

• Brand Name: FEMALE CATH KIT, WITH VINYL GLOVES, SWABS, LUBRICANT AND TOWEL, SOFT, 8 FR.
• Type of Device: FEMALE CATHETER KIT
• 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: amy gravley ; 8195 industrial blvd; covington, GA 30014 ; 7707846100
• MDR Report Key: 6391294
• MDR Text Key: 69855804
• Report Number: 1018233-2017-00974
• Device Sequence Number: 1
• Product Code: FFH
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K905016
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 05/12/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/09/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2018
• Device Catalogue Number: 0035720
• Device Lot Number: NGAX1795
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 04/18/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/28/2016
• 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 Age: 2 YR
• Patient Weight: 14