MAUDE Adverse Event Report: C.R. BARD, INC. (COVINGTON) -1018233 UNKNOWN SILICONE TEMP-SENSING CATHETER

Catalog Number UNKNOWN

Device Problem Partial Blockage (1065)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/15/2021

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 the blue cap from the sampling port of the drain bag had come off and a foam tape was used to prevent from leaking.It was noted that the catheter was placed from (b)(6) 2021 to (b)(6) 2021 and curos caps were not used to clean the port and soap and water were used to clean the mucus membrane and hcg was used on the rest of the area.Customer had stated that this had occurred multiple times and seemed to occur primarily with temperature sensing catheters.Representative manipulated the sampling port of tray a319516am, lot ngex3125 with and without syringe and observed that the port did not move.Also, reported that the drain bags leaked from the seams when full and the tamper evident seal unraveled after being opened.It was also reported that there were incidents where catheters eyelet was obstructed.Customer was provided with education and training on what to do for the above two incidents.

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 the blue cap from the sampling port of the drain bag had come off and a foam tape was used to prevent from leaking.It was noted that the catheter was placed from (b)(6) 2021 and curos caps were not used to clean the port and soap and water were used to clean the mucus membrane and hcg was used on the rest of the area.Customer had stated that this had occurred multiple times and seemed to occur primarily with temperature sensing catheters.Representative manipulated the sampling port of tray a319516am, lot ngex3125 with and without syringe and observed that the port did not move.Also, reported that the drain bags leaked from the seams when full and the tamper evident seal unraveled after being opened.It was also reported that there were incidents where catheters eyelet was obstructed.Customer was provided with education and training for the above two incidents.

Manufacturer Narrative

The reported event was inconclusive because no sample was returned.A potential root cause for this failure could be ¿occlusion from biological materials".It is unknown whether the device had met relevant specifications.The product was used for treatment purposes.It was unknown whether the product had caused the reported failure.The dhr review could not be performed without a lot number.The product catalog number and the lot number for this device are unknown.Therefore, bd is unable to determine the associated labeling to review.H11: section a through f - 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 blue cap from the sampling port of the drain bag had come off and a foam tape was used to prevent from leaking.It was noted that the catheter was placed from (b)(6) 2021 to (b)(6) 2021 and curos caps were not used to clean the port and soap and water were used to clean the mucus membrane and hcg was used on the rest of the area.Customer had stated that this had occurred multiple times and seemed to occur primarily with temperature sensing catheters.Representative manipulated the sampling port of tray a319516am, lot ngex3125 with and without syringe and observed that the port did not move.Also, reported that the drain bags leaked from the seams when full and the tamper evident seal unraveled after being opened.It was also reported that there were incidents where catheters eyelet was obstructed.Customer was provided with education and training for the above two incidents.

• Brand Name: UNKNOWN SILICONE TEMP-SENSING CATHETER
• Type of Device: UNKNOWN SILICONE TEMP-SENSING CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington 30014
• MDR Report Key: 11625118
• MDR Text Key: 244160450
• Report Number: 1018233-2021-01923
• Device Sequence Number: 1
• Product Code: EZL
• Combination Product (y/n): N
• PMA/PMN Number: K070582
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,other,use
• Type of Report: Initial,Followup,Followup
• Report Date: 07/23/2021

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 Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Returned to Manufacturer: 03/18/2021
• Initial Date Manufacturer Received: 03/15/2021
• Initial Date FDA Received: 04/06/2021
• Supplement Dates Manufacturer Received: 04/27/2021; 07/20/2021
• Supplement Dates FDA Received: 05/21/2021; 08/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other