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

Model Number	772416
Medical Device Problem Code	Use of Device Problem (1670)
Health Effect - Clinical Codes	Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.
Event or Problem 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 or Problem 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.
Additional 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.
Additional 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 or Problem 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
• Common Device Name: SILICONE CATHETER
• Manufacturer (Section D): C.R. BARD, INC. (COVINGTON) -1018233; 8195 industrial blvd; covington GA 30014
• MDR Report Key: 8075323
• Report Number: 1018233-2018-05443
• Device Sequence Number: 18848080
• Product Code: EZL
• UDI-Device Identifier: 00801741030420
• UDI-Public: (01)00801741030420
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K040504
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 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
• Operator of Device: 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 Received by Manufacturer: 10/23/2018
• Supplement Date Received by Manufacturer: 01/31/2019; 04/24/2019
• Initial Report FDA Received Date: 11/15/2018
• Supplement Report FDA Received Date: 02/04/2019; 05/13/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1