MAUDE Adverse Event Report: C.R. BARD INC. (COVINGTON) -1018233 BARDEX® I.C. TIEMANN MODEL COUDE TIP FOLEY CATHETER

Catalog Number	0102SI22
Medical Device Problem Code	Material Puncture/Hole (1504)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/07/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a: through f: the information provided by bd represents all 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 bd.
Event or Problem Description
It was reported that patient had foley catheter exchanged on 2(b)(6) 024 after being admitted.Foley was draining all day.Patient placed in bed at 12.30.Around 13.00 patient called and stated that they felt like their catheter was leaking.Writer went to room and found that foley had fallen out and balloon was not inflated.They wanted to place a new catheter and wondered what would happen if they inflated the balloon.Balloon was inflated and saline shot out of the tube that connected the balloon port.Must have been defective or broke sometime after foley was placed.Foley was saved and placed in specimen bag.
Event or Problem Description
It was reported that patient had foley catheter exchanged on 06feb2024 after being admitted.Foley was draining all day.Patient placed in bed at 12.30.Around 13.00 patient called and stated that they felt like their catheter was leaking.Writer went to room and found that foley had fallen out and balloon was not inflated.They wanted to place a new catheter and wondered what would happen if they inflated the balloon.Balloon was inflated and saline shot out of the tube that connected the balloon port.Must have been defective or broke sometime after foley was placed.Foley was saved and placed in specimen bag.
Additional Manufacturer Narrative
The reported event was confirmed cause unknown.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley catheter.Visual inspection of the sample noted the catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water) and immediately leaked from pinhole in inflation funnel measuring (.013").A root cause could not be definitively identified, based on the risk documentation review, a potential root cause for this type of failure could be ¿insufficient latex strength, low/non-uniform rubberize thickness, wire pressing technique, stripping technique etc.That cause the torn rubberize¿.The device history record review could not be performed without a lot number."the instructions for use were found adequate and state the following" warning: on catheter, do not use ointments or lubricants having petrolatum base.They will damage latex and may cause the balloon to burst.Caution: do not aspirate urine through drainage funnel wall.Storage: store catheters at room temperature away from direct exposure to light, preferably in the original box.Recommended inflation capacities 3cc balloon: use 5cc sterile water 5cc balloon: use 10cc sterile water 30cc balloon: use 35cc sterile water warning: after use, this product may be a potential biohazard.Handle and dispose of in accordance with applicable local, state, and federal laws and regulations.Catheters should be replaced in accordance with the cdc guideline, "guideline for prevention of catheter-associated urinary tract infection." at the onset or first signs of a urinary tract infection, catheter encrustation, or any other catheterrelated adverse effect, the catheter should be replaced to deflate catheter balloon: gently insert a luer slip syringe in the catheter valve.Never use more force than is required to make the syringe "stick" in the valve.Allow the pressure within the balloon to force the plunger back and fill the syringe with water.If you notice slow or no deflation, re-seat the syringe gently.Use only gentle aspiration to encourage deflation if needed.Vigorous aspiration may collapse the inflation lumen, preventing balloon deflation.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.Correction: d, g.H11: section a through f - the information provided by bd represents all 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 bd.

• Brand Name: BARDEX® I.C. TIEMANN MODEL COUDE TIP FOLEY CATHETER
• Common Device Name: FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer (Section G): C.R. BARD INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• Manufacturer Contact: xeeroy rada ; 8195 industrial blvd; covington 30014 ; 7707846100
• MDR Report Key: 18808589
• Report Number: 1018233-2024-01066
• Device Sequence Number: 12595418
• Product Code: MJC
• UDI-Device Identifier: 00801741017100
• UDI-Public: (01)00801741017100
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K910318
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/11/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 0102SI22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/09/2024
• Supplement Date Received by Manufacturer: 06/11/2024
• Initial Report FDA Received Date: 02/29/2024
• Supplement Report FDA Received Date: 06/14/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown