MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® I.C. FOLEY CATHETER; FOLEY CATHETER (LATEX)

Catalog Number 0165SI12

Device Problem Break (1069)

Patient Problems Death (1802); Pneumonia (2011); Respiratory Distress (2045); No Consequences Or Impact To Patient (2199)

Event Date 09/23/2019

Event Type  malfunction  

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.

Event Description

It was reported that a foley catheter broke while it was in the patient.The foley catheter was already in use for three days when it was found.On (b)(6) 2019, the terminally ill patient had an episode of confusion and may have pulled the foley catheter.The broken portion with the balloon remained in the patient¿s body.The patient expired on (b)(6) 2019 with the broken piece remaining in the body.According to the physician, the patient¿s death was not device related.Additional information was requested via email on 3-oct-2019 and as per the information received, the patient was admitted to the hospital with cirrhosis,interstitial pneumonia and suspected recurrent hepatic tumor.It was confirmed that the cause of the death was due to acute respiratory distress syndrome (ards) and interstitial pneumonia.

Manufacturer Narrative

The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.Correction: d1 (brand name), d4 (lot#).H11:section a through f - the information provided by bd 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 bd.

Event Description

It was reported that a foley catheter broke while it was in the patient.The foley catheter was already in use for three days when it was found.On (b)(6) 2019, the terminally ill patient had an episode of confusion and may have pulled the foley catheter.The broken portion with the balloon remained in the patient¿s body.The patient expired on (b)(6) 2019 with the broken piece remaining in the body.According to the physician, the patient¿s death was not device related.Additional information was requested via email on 3-oct-2019 and as per the information received, the patient was admitted to the hospital with cirrhosis, interstitial pneumonia and suspected recurrent hepatic tumor.It was confirmed that the cause of the death was due to acute respiratory distress syndrome (ards) and interstitial pneumonia.

Event Description

It was reported that a foley catheter broke while it was in the patient.The foley catheter was already in use for three days when it was found.On (b)(6)2019, the terminally ill patient had an episode of confusion and may have pulled the foley catheter.The broken portion with the balloon remained in the patient¿s body.The patient expired on (b)(6)2019 with the broken piece remaining in the body.According to the physician, the patient¿s death was not device related.Additional information was requested via email on (b)(6) 2019 and as per the information received, the patient was admitted to the hospital with cirrhosis,interstitial pneumonia and suspected recurrent hepatic tumor.It was confirmed that the cause of the death was due to acute respiratory distress syndrome (ards) and interstitial pneumonia.

Manufacturer Narrative

The reported event was confirmed as cause unknown.The evaluation observed the catheter was split into 2 pieces.The surface was normal in appearance with the presence of smooth and clear cut.The catheter shaft appears to have been cut by sharp tools i.E.Scissors that could cause the catheter split into two.The unit was inspected for the presence of oxidation, acid cuts, abrasions, external cuts or tears that could cause the shaft to cut.None of the conditions above were evident on the sample.A potential root cause for this failure mode could be due to lower latex/over chlorination/user related (pulling by user/ expose to sharp object).How and when problem occurred could not be determined.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The instructions for use were found adequate and state the following: ¿(1) do not inflate the balloon in the urethra.[the urethra may be injured.] (2) do not pull the catheter hard.[the bladder/urethra may be injured.] 2.Applicable patients (1) patients with delirium who might pull out catheter [when patient tugs at catheter unconsciously, the bladder and urethra may be damaged.] [contraindications] 1.Method for use: (1) do not reuse.(2) do not resterilize.(3) this device contains 10% povidone-iodine.For patients with past history of allergic hypersensitivity to povidone-iodine or iodine, consider using alternative disinfectants.(4) be careful that the catheter is not exposed to ointments, contrast medium or oil-based lubricants (including vegetable oils such as olive oil, mineral oils such as white petrolatum and animal oils).[they may damage the device and may burst balloon.] (5) do not hold the device with forceps, etc.Avoid contact with any blades or sharp-edged instruments.[catheter damage may cause balloon rupture and accidental balloon removal or failure to deflate or remove the balloon.] 2.Applicable patients (1) do not use in patients who are or have been allergic to natural rubber latex.".

• Brand Name: BARDEX® I.C. FOLEY CATHETER
• Type of Device: FOLEY CATHETER (LATEX)
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9214252
• MDR Text Key: 184460897
• Report Number: 1018233-2019-06611
• Device Sequence Number: 1
• Product Code: MJC
• Combination Product (y/n): N
• PMA/PMN Number: K910318
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Type of Report: Initial,Followup,Followup
• Report Date: 11/22/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/21/2019
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/28/2022
• Device Catalogue Number: 0165SI12
• Device Lot Number: MYDS2917
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/14/2019
• Date Manufacturer Received: 11/19/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 78 YR