MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER; SILICONE TEMP SENSING FOLEY CATHETER

Model Number 119108

Device Problems Break (1069); Crack (1135); Deflation Problem (1149)

Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)

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 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 the rn noticed a crack in the system as she was inflating balloon.Per additional information received from the complainant via email on (b)(6) 2019, the crack was located in the balloon of the catheter.

Event Description

It was reported that the rn noticed a crack in the system as she was inflating balloon.Per additional information received from the complainant via email on 16 aug 2019, the crack was located in the balloon of the catheter.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.A visual evaluation of the returned sample noted one opened (with original packaging), 3-way temperature sensing silicone foley catheter with connected sample port connector (intact tamper evident seal), inflation syringe, inlet tube, and meter drain bag.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was attempted to be inflated with 3.5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and immediately leaked form a pinhole (measuring 0.0540 inches) located just under the cap on the inflation port.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: "visually inspect the product for any imperfections or surface deterioration prior to use." correction: h6.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.

Manufacturer Narrative

The reported event was confirmed as manufacturing related.A visual evaluation of the returned sample noted one opened (with original packaging), 3-way temperature sensing silicone foley catheter with connected sample port connector (intact tamper evident seal), inflation syringe, inlet tube, and meter drain bag.Visual inspection of the sample noted no obvious visible defects.The catheter balloon was attempted to be inflated with 3.5 ml methylene blue solution (3 drops 1% aq methylene blue per 100ml distilled water), and immediately leaked form a pinhole (measuring 0.0540 inches) located just under the cap on the inflation port.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: "visually inspect the product for any imperfections or surface deterioration prior to use." 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 the rn noticed a crack in the system as she was inflating balloon.Per additional information received from the complainant via email on 16 aug 2019, the crack was located in the balloon of the catheter.

• Brand Name: BARDEX® ALL-SILICONE TEMPERATURE-SENSING PEDIATRIC FOLEY CATHETER
• Type of Device: SILICONE TEMP SENSING FOLEY CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8927715
• MDR Text Key: 193983018
• Report Number: 1018233-2019-05051
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741045998
• UDI-Public: (01)00801741045998
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 11/11/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 10/31/2023
• Device Model Number: 119108
• Device Catalogue Number: 119108
• Device Lot Number: NGCX4626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/22/2019
• Initial Date Manufacturer Received: 08/02/2019
• Initial Date FDA Received: 08/23/2019
• Supplement Dates Manufacturer Received: 09/19/2019; 11/07/2019
• Supplement Dates FDA Received: 09/23/2019; 11/11/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1