MAUDE Adverse Event Report: COLOPLAST A/S BONEE NEEDLE 35; BLADDER INJECTION

Model Number NBI0351002

Device Problem Disconnection (1171)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 01/08/2016

Event Type  malfunction  

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 of conclusions contained in the original mdr or in any prior supplemental reports, a follow-up report will be submitted.

Event Description

According to the available information, during injection in a child (one patient), of vesical botox by cystoscopy, the tip of the 2 injection needles dismantled in the bladder, on 2 needles of the same lot number.Two needles were found and withdrawn by endoscopy without laparotomy.No clinical consequences but tripled duration of procedure.(usually 40 minutes to 120 minutes in this incident).

• Brand Name: BONEE NEEDLE 35
• Type of Device: BLADDER INJECTION
• Manufacturer (Section D): COLOPLAST A/S; holtedam 1; humlebaek, da 3050 ; DA 3050
• Manufacturer (Section G): COLOPLAST MANUFACTURING US, LLC; 1601 west river road north; minneapolis MN 55411
• Manufacturer Contact: christine buckvold ; 1601 west river road north; minneapolis, MN 55411 ; 6123024982
• MDR Report Key: 5468490
• MDR Text Key: 39553538
• Report Number: 9610711-2016-00009
• 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
• Type of Report: Initial
• Report Date: 02/29/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/29/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Expiration Date: 12/20/2017
• Device Model Number: NBI0351002
• Device Catalogue Number: NBI0351002
• Device Lot Number: 3961689
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/04/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 10 YR