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

Model Number 772416

Device Problems Use of Device Problem (1670); Material Integrity Problem (2978)

Patient Problems Patient Problem/Medical Problem (2688); 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.

Event Description

It was reported that the patient had a catheter with an additional "ring" on the end inserted.Upon removal of the catheter, the patient allegedly experienced trauma and self-limited bleeding.It was advised to monitor the patient for any further complications.No medical intervention was reported.

Event Description

It was reported that the patient had a catheter with an additional "ring" on the end inserted.Upon removal of the catheter, the patient allegedly experienced trauma and self-limited bleeding.It was advised to monitor the patient for any further complications.No medical intervention was reported.

Manufacturer Narrative

The reported event was confirmed as use related since after balloon was inflated and passively deflated, the cuffing did not occur.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley with the inflation and drainage valve cut off and cuffing in the balloon.The catheter balloon was inflated with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water), but the catheter balloon could not hold water due to the missing valves.The cuffing disappeared after the water was passively drained from the inflation lumen.No further testing could be done due to the missing valves.The reported event was confirmed as use related since after balloon was inflated and passively deflated, the cuffing did not occur.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley with the inflation and drainage valve cut off and cuffing in the balloon.The catheter balloon was inflated with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water), but the catheter balloon could not hold water due to the missing valves.The cuffing disappeared after the water was passively drained from the inflation lumen.No further testing could be done due to the missing valves.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The product family for this foley catheter product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the urinary drainage product ifus are found to be adequate based on past reviews.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 use related since after balloon was inflated and passively deflated, the cuffing did not occur.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley with the inflation and drainage valve cut off and cuffing in the balloon.The catheter balloon was inflated with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water), but the catheter balloon could not hold water due to the missing valves.The cuffing disappeared after the water was passively drained from the inflation lumen.No further testing could be done due to the missing valves.The reported event was confirmed as use related since after balloon was inflated and passively deflated, the cuffing did not occur.Visual evaluation of the returned sample noted one opened (without original packaging), used silicone foley with the inflation and drainage valve cut off and cuffing in the balloon.The catheter balloon was inflated with methylene blue solution (3 drops 1% aq methylene blue per 100ml of distilled water), but the catheter balloon could not hold water due to the missing valves.The cuffing disappeared after the water was passively drained from the inflation lumen.No further testing could be done due to the missing valves.The device history record was reviewed and found nothing that could have caused or contributed to the reported event.The product family for this foley catheter product is unknown.Therefore, bard is unable to determine the associated labeling to review.Although the product family is unknown, the urinary drainage product ifus are found to be adequate based on past reviews.

Event Description

It was reported that the patient had a catheter with an additional "ring" on the end inserted.Upon removal of the catheter, the patient allegedly experienced trauma and self-limited bleeding.It was advised to monitor the patient for any further complications.No medical intervention was reported.

• Brand Name: ALL SILICONE CATHETER
• Type of Device: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8075323
• MDR Text Key: 127408953
• Report Number: 1018233-2018-05443
• Device Sequence Number: 1
• Product Code: EZL
• UDI-Device Identifier: 00801741030420
• UDI-Public: (01)00801741030420
• Combination Product (y/n): N
• PMA/PMN Number: K040504
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: user facility
• Type of Report: Initial,Followup,Followup
• Report Date: 05/13/2019

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 Model Number: 772416
• Device Catalogue Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/06/2018
• Initial Date Manufacturer Received: 10/23/2018
• Initial Date FDA Received: 11/15/2018
• Supplement Dates Manufacturer Received: 01/31/2019; 04/24/2019
• Supplement Dates FDA Received: 02/04/2019; 05/13/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1