MAUDE Adverse Event Report: COLOPLAST A/S BONEE NEEDLE; BLADDER INJECTION NEEDLE

Model Number NBI0352002

Device Problem Material Too Soft/Flexible (4007)

Patient Problem Pain (1994)

Event Date 05/16/2023

Event Type  Injury  

Manufacturer Narrative

Without the benefit of examination and testing, coloplast is precluded from commenting on the condition of the device or the cause of the occurrence.Should additional facts prompt us to alter or supplement any information or conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to available information, the patient with this device experienced pain.The device was too flexible and had difficulty entering the bladder wall.The device had to be pressed much harder to enter.During the surgical procedure, the patient had acute pain.No other adverse patient effects were reported.

Manufacturer Narrative

We have been informed about a defect product, flexible needle, on a bonee needle.According to the complaint description lot number and sample are unavailable.Checking the quality databases did not reveal any anomaly in relation to the described defect.A similar case study was done based on same item number, same defect over last four year: no similar case was found.The clinical assessment concluded: the use of bonee is a standard part of urological practice.This type of medical device must only be used by trained and experienced professionals.Bonee (needle for bladder injection) is routinely used to deliver injectable materials (amongst other botulinum toxin*), into the urinary bladder wall during the transurethral endoscopic procedures.This type of medical device must only be used by trained and experienced professionals.Generally, the difficulty of the needle piercing the bladder wall can be associated in the worst-case figure with clinical severity 3 for pain, infection, bleeding, mucosal lesions/tissue lesion, bladder spasm, needle breakage during the procedure with need for re-surgery for withdrawal of needle lost in the bladder.For these complaints the risk evaluation has been done based on the risk criteria from the procedure for risk management reference sba06023.The evaluation has showed that risks are adequately controlled and reduced as far as possible in the state of art.Based on this, we can conclude that residual risks are adequately controlled and reduced as far as possible, and the residual risks associated with the use of the product are acceptable when weighed against the benefits to the patient/user.It is concluded that the risks identified are still acceptable and considered as safe.

• Brand Name: BONEE NEEDLE
• Type of Device: BLADDER INJECTION NEEDLE
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebæk 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST A/S MANUFACTURING; 9 avenue edmond rostand; sarlat-la-caneda 24206 ; FR 24206
• Manufacturer Contact: usbes brian e schmidt ; 1601 west river road north; minneapolis, MN 55411 ; 8007880293
• MDR Report Key: 17094936
• MDR Text Key: 316845742
• Report Number: 9610711-2023-00127
• Device Sequence Number: 1
• Product Code: FBK
• Combination Product (y/n): N
• PMA/PMN Number: K090217
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/08/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NBI0352002
• Device Catalogue Number: NBI035
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/30/2023
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/23/2023
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention