MAUDE Adverse Event Report: PRODUCTOS PARA EL CUIDADO DE LA SALUD -9611590 BARDEX 2-WAY 3CC ALL-SILICONE PEDIATRIC FOLEY CATHETER, SHORT LENGTH,ROUND TIP; SILICONE CATHETER

Catalog Number 165808

Device Problems Difficult to Remove (1528); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bruise/Contusion (1754); Pain (1994); Swelling (2091)

Event Date 03/03/2017

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 the silicone catheter balloon had been deflated; however, there was allegedly resistance during removal.It was later reported that the nursing staff had difficulty removing the foley catheter on a male patient.The catheter had been in situ for 2 days.The patient allegedly experienced pain/trauma during removal and developed bruising/swelling around the urethra and scrotum.It also was noted that the balloon had cuffed, and was therefore difficult to remove.App.10 mls of fluid was removed during the deflation attempt.The balloon deflated by passive deflation, and was further aspirated at the end of the passive deflation to ensure full deflation.To remove the catheter, the patient had lignocaine gel applied to the meatus, as this was where the cuff was stuck.The catheter was twisted and pulled with more force than required, while trying to pull the tip over the cuff.The patient was not too uncomfortable after the lignocaine gel was applied.The patient had ice applied to the scrotum.The patient also had a scan and iv antibiotics for 24 hours.The territory manager is scheduled to conduct educational sessions on catheter care and maintenance, to include passive deflation.

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 the silicone catheter balloon had been deflated; however, there was allegedly resistance during removal.It was later reported that the nursing staff had difficulty removing the foley catheter on a male patient.The catheter had been in situ for 2 days.The patient allegedly experienced pain/trauma during removal and developed bruising/swelling around the urethra and scrotum.It also was noted that the balloon had cuffed, and was therefore difficult to remove.App.10 mls of fluid was removed during the deflation attempt.The balloon deflated by passive deflation, and was further aspirated at the end of the passive deflation to ensure full deflation.To remove the catheter, the patient had lignocaine gel applied to the meatus, as this was where the cuff was stuck.The catheter was twisted and pulled with more force than required, while trying to pull the tip over the cuff.The patient was not too uncomfortable after the lignocaine gel was applied.The patient had ice applied to the scrotum.The patient also had a scan and iv antibiotics for 24 hours.The territory manager is scheduled to conduct educational sessions on catheter care and maintenance, to include passive deflation.

Manufacturer Narrative

No physical sample was returned for evaluation.However; photos of the involved product were provided.Per photo inspection, it was noted that the catheter had a deflated balloon and a cuff-roll.The reported event was confirmed with an unknown cause.The lot number is unknown; therefore, the device history record could not be reviewed.The instructions for use states the following: "recommended inflation capacities 3cc balloon: use 5ml sterile water, 5cc balloon: use 10ml sterile water, 30cc balloon: use 35ml sterile water, do not exceed recommended capacities.To deflate catheter balloon: gently insert a syringe in the catheter valve.Never use more force than is required to make the syringe ¿stick¿ in the valve.If you notice slow or no deflation, re-seat the syringe gently.Allow the balloon to deflate slowly on its own.Do not aspirate or manually accelerate the deflation of the balloon.If permitted by hospital protocol, the valve arm may be severed.If this fails, contact adequately trained professional for assistance, as directed by hospital protocol.Visually inspect the product for any imperfections or surface deterioration prior to use." (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.Received photo sample only.

Event Description

It was reported that the silicone catheter balloon had been deflated; however, there was allegedly resistance during removal.It was later reported that the nursing staff had difficulty removing the foley catheter on a male patient.The catheter had been in situ for 2 days.The patient allegedly experienced pain/trauma during removal and developed bruising/swelling around the urethra and scrotum.It also was noted that the balloon had cuffed, and was therefore difficult to remove.App.10 mls of fluid was removed during the deflation attempt.The balloon deflated by passive deflation, and was further aspirated at the end of the passive deflation to ensure full deflation.To remove the catheter, the patient had lignocaine gel applied to the meatus, as this was where the cuff was stuck.The catheter was twisted and pulled with more force than required, while trying to pull the tip over the cuff.The patient was not too uncomfortable after the lignocaine gel was applied.The patient had ice applied to the scrotum.The patient also had a scan and iv antibiotics for 24 hours.The territory manager is scheduled to conduct educational sessions on catheter care and maintenance, to include passive deflation.

• Brand Name: BARDEX 2-WAY 3CC ALL-SILICONE PEDIATRIC FOLEY CATHETER, SHORT LENGTH,ROUND TIP
• Type of Device: SILICONE CATHETER
• 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: 6433043
• MDR Text Key: 70857614
• Report Number: 1018233-2017-01342
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• Reporter Country Code: AU
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 06/02/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 165808
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/05/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/03/2017
• Initial Date FDA Received: 03/24/2017
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 04/20/2017; 06/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• 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): Required Intervention