MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER; FOLEY CATHETERS

Catalog Number 175816

Device Problems Material Invagination (1336); Structural Problem (2506)

Patient Problems Pain (1994); Urinary Retention (2119)

Event Date 12/23/2019

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 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 the during discontinuation, the foley catheter folded around the tube instead of going back to its original shape, which caused retention and increased pain.A rapid response was called and the patient was treated with 1gm of hydromorphone and topical lidocaine, and the foley was discontinued.

Event Description

It was reported the during discontinuation, the foley catheter folded around the tube instead of going back to its original shape, which caused retention and increased pain.A rapid response was called and the patient was treated with1 gm of hydromorphone and topical lidocaine, and the foley was discontinued.

Manufacturer Narrative

The reported event was unconfirmed since the reported failure could not be reproduced.The device met the relevant specifications.The product was intended to be used for treatment purposes.The product was not related to the reported failure.Visual evaluation of the returned sample noted one opened (without original packaging), silicone foley catheter.Visual inspection of the sample noted no obvious visible defects.There was no cuffing visible in the balloon on return.The catheter balloon was inflated with 10 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water).The balloon concentricity was observed to be 50:50.The balloon rested for 30 minutes without leaks and passively deflated without issue, returning 10ml of solution.No cuffing was noted.The active length of the catheter balloon was measured (0.6780 inches) and found to be within specification.The catheter was confirmed to be size 16 fr.No root cause could be found because the reported event was unconfirmed.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: ¿instrumentation during urological procedures.Hydrophilic guidewires are offered in many different configurations that include: sizes (lengths and diameters), tip designs, and stiffness.The bard® nicore¿ wire has a nitinol core and a hydrophilic coating.The bard® hydro-glide¿ stainless steel guidewires are available with a hydrophilic coating.Indications: bard® guidewires are indicated to provide transurethral and/or percutaneous access into the bladder, ureter or renal pelvis.Contraindications: there are no known contraindications warning: inspect all guidewires for damage prior to use.Bending or kinking during or prior to placement could damage the guidewire.Do not attempt to use the guidewire if it has been damaged.Use of a damaged wire may result in damage to the urinary tract.Do not reshape the guidewire by any means.Attempting to reshape the guidewire may cause damage resulting in release of fragments into the urinary tract.Failure to exercise proper caution may result in damage to the urinary tract.Do not manipulate or remove the guidewire through a metal cannula or needle.This may result in destruction/separation of the outer jacket of the wire requiring retrieval.Use extreme caution when using a laser, making sure to avoid contact with the wire.Direct contact could result in damage / breakage to the wire.Attention should be paid to guidewire movement in the urinary tract.Before a guidewire is moved or torqued, tip movement should be examined under direct vision or fluoroscopy.Do not advance or withdraw a guidewire when resistance is encountered as perforation could occur.Sufficient guidewire length must remain exposed to maintain a firm grip on guidewire at all times.Failure to comply with the warnings could result in damage to the guidewire to include, but not limited to: wire breakage, abrasion of the coating, release of guidewire fragments into the urinary system, all of which might require intervention.This is a single use device.Do not resterilize any portion of this device.Reuse and/ or repackaging may create a risk of patient or user infection, compromise the structural integrity and/or essential material and design characteristics of device, which may lead to device failure, and/or lead to injury, illness or death of the patient." 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.

• Brand Name: BARDEX® LUBRI-SIL® ALL-SILICONE FOLEY CATHETER
• Type of Device: FOLEY CATHETERS
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 9672217
• MDR Text Key: 177968406
• Report Number: 1018233-2020-00777
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741180484
• UDI-Public: (01)00801741180484
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/05/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 175816
• Device Lot Number: NGDU1211
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/29/2020
• Date Manufacturer Received: 02/27/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 66 YR
• Patient Weight: 79