MAUDE Adverse Event Report: BECTON DICKINSON RAY BONANNO CATHETER S/SU; CATHETER AND TUBE, SUPRAPUBIC

Catalog Number 408289

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Hematuria (2558)

Event Date 09/29/2023

Event Type  Injury  

Manufacturer Narrative

Pr (b)(4).Initial mdr submission.A follow up mdr will be submitted if additional information becomes available.Device problem code: a24 - adverse event without identified device or use problem patient problem codes: f08 - hospitalization or prolonged hospitalization.

Event Description

This is mdr 2 of 3 (patient 3) customer advised that bladder perforations had occurred with 3 patients following insertion of bonanno suprapubic catheters.These incidents are going to be investigated by the hospital to try to identify if this is product or user related.No lot numbers or samples are available, although these will be tracked for future patients.3x patients with bladder perforations.1 patient also suffered a cardiac arrest.Additional information: 11-oct-2023 - received an email response from complainant for information requested.Answers added in follow up tab.Refer email attached.1.Was there any harm to the patient/caregiver? (detail) patient 1: yes - bladder injury, haematuria, unplanned return to theatre (laparotomy post cardiac arrest), icu admission, extended length of stay (from 4 days to 17days), later re-admission for cystoscopy patient 2: yes ¿ bladder perforation on ct, abdo pain, extended length of stay (from 4 days to 13 days) patient 3: yes ¿ bladder injury, haematuria, unplanned return to theatre (cystoscopy), extended length of stay (from 4 days to 8 days) 2.Did three patients experience bladder perforation and one of those patients experiences cardiac arrest as well? or was there four patients involved? three (3) patients with bladder injury/perforation with one as above requiring icu admission as a result 3.Was there a need for medical and/or surgical intervention due to the incident (imaging tests, surgery, medication administration, etc.)? (detail) yes ¿ patient 1 & patient 3 for return to theatre, all patients had interventions with medication/fluids, patient¿s 1 & 2 had imaging tests 4.Any other actions taken? yes ¿ requested further education from company on product insertion and removal theatre staff now recording lot numbers when opening in theatre to patient medical record isolation of all bonnano spc¿s on removal and held until patient is discharged to aid in qa investigation with manufacturer 5.Any visible damage observed on the product? nil at time of removal however all 3 cases had a delayed effect with symptoms of haematuria etc.Spc¿s had been discarded by this stage and unable to be reviewed 6.How was the catheter inserted?, please provide details/instructions.Vmo surgeon in theatre with over 30 years of experience with these spc¿s ¿ dr (b)(6) cases anterior and posterior vaginal repairs, sacrospinous hitch for prolapse ¿ patient 2 also had vaginal hysterectomy 7.Occurrence date of incident.Patient 1 - (b)(6) 2023.Patient 2 ¿ (b)(6) 2023.Patient 3 --- (b)(6) 2023.

Event Description

No additional information received customer advised that bladder perforations had occurred with 3 patients following insertion of bonanno suprapubic catheters.These incidents are going to be investigated by the hospital to try to identify if this is product or user related.No lot numbers or samples are available, although these will be tracked for future patients.3x patients with bladder perforations.1 patient also suffered a cardiac arrest.

Manufacturer Narrative

Investigation summary: no sample or photos received by our quality team for investigation.The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed.Bd was not able to confirm customer¿s reported failure.It is important to follow the instructions for use for this product."for proper use, clinicians should be trained in the use of this device.Use the device in conjunction with your facility protocol and reintroduction of the introducer needle must not be attempted.To ensure patient safety, the needle should be handled with care and discarded if damaged.Fluid leakage around the insertion site may indicate catheter damage.Notify the physician immediately.If the bladder is not palpable following pre-procedure preparations, this device should not be used, the procedure should be abandoned, and a foley-type catheter inserted into the bladder through the urethra" in the caution section of the product for catalog 408289 states: "following the introduction of the bonanno catheter, and after the steel puncture needle has been removed, reintroduction of the needle must not be attempted".Based on the quality team's investigation, we are not able to identify a root cause related to our manufacturing process at this time.

• Brand Name: RAY BONANNO CATHETER S/SU
• Type of Device: CATHETER AND TUBE, SUPRAPUBIC
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD CARIBE LTD.; road 31; k.m. 24.3; juncos IA 60061
• Manufacturer Contact: helen cox ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 17938906
• MDR Text Key: 325720855
• Report Number: 2618282-2023-00084
• Device Sequence Number: 1
• Product Code: FEZ
• UDI-Device Identifier: 00382904082895
• UDI-Public: (01)00382904082895
• Combination Product (y/n): N
• Reporter Country Code: AS
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/09/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 408289
• Device Lot Number: UNKNOWN
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/09/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention