MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD NEOFLON¿ IV CANNULA 24 G X 19 MM IV CATHETER

Catalog Number 391350

Device Problems Peeled/Delaminated (1454); Device Operates Differently Than Expected (2913)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 09/15/2017

Event Type  malfunction  

Manufacturer Narrative

Incorrect awareness date entered on initial mdr. Correction date of 10/02/2017 has been made investigation summary: 1 representative sample was returned for investigation. The sample was subjected to visual inspection. Peelback was not observed on the representative sample. Catheter bevel angle and catheter tip od measurement had performed on the representative sample and the result met the product specification. Catheter curl was observed on the sample in the photo. The actual sample was not returned for further investigation. Thus, no root cause can be determined. Investigation conclusion: catheter curl was observed on the sample in the photo. Root cause description root cause: the actual sample was not returned for further investigation. Thus, no root cause can be determined. Dhr review - no complaint related qn and deviations is raised on the involved batch.

Manufacturer Narrative

(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that several bd neoflon¿ iv cannula 24 g x 19 mm had peel back malfunctions during use. One child had to be moved to another hospital due to unsuccessfully starting an infusion catheter on the baby. There was no report of injury or medical intervention.

• Brand Name: BD NEOFLON¿ IV CANNULA 24 G X 19 MM
• Type of Device: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6984457
• MDR Text Key: 245850328
• Report Number: 8041187-2017-00137
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: NL
• PMA/PMN Number: K011103
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility

Reporter Occupation

• Type of Report: Initial,Followup
• Report Date: 11/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 08/31/2021
• Device Catalogue Number: 391350
• Device Lot Number: 6230408
• Was Device Available for Evaluation?: No Answer Provided
• Is the Reporter a Health Professional?: No

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 10/02/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/26/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial

Patient Treatment Data

Date Received: 10/27/2017 Patient Sequence Number: 1