MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 20 GA 2.00 IN; INTERVASCULAR CATHETER

Model Number	386812
Medical Device Problem Codes	Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	08/27/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that an unspecified number of bd cathena safety iv catheters with wings bd multiguard technology 20 ga 2.00 in experienced catheter damage/deformation during use.The following information was provided by the initial reporter: breaking of the plastic portion of the cannula.Damage is on the cutting edge of the needle.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2020-10-12.H6: investigation summary one sample was received by our quality team for evaluation.From the sample, a v-shaped cut was observed on the catheter, confirming the customer experience.A review of the internal manufacturing device records and raw material history files for the reported lot numbers was performed and no recorded quality problems or rejections to this incident were found.The v-shape cut observed on the catheter is due to product manipulation as the sample returned was contaminated with blood.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.
Event or Problem Description
It was reported that an unspecified number of bd cathena safety iv catheters with wings bd multiguard technology 20 ga 2.00 in experienced catheter damage/deformation during use.The following information was provided by the initial reporter: breaking of the plastic portion of the cannula.Damage is on the cutting edge of the needle.

• Brand Name: BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY 20 GA 2.00 IN
• Common Device Name: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10577949
• Report Number: 8041187-2020-00609
• Device Sequence Number: 17115087
• Product Code: FOZ
• UDI-Device Identifier: 00382903868124
• UDI-Public: 00382903868124
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: NA
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 11/12/2020

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: Other
• Device Expiration Date: 05/31/2021
• Device Model Number: 386812
• Device Catalogue Number: 386812
• Device Lot Number: 8116297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/12/2020
• Initial Date Received by Manufacturer: 09/02/2020
• Supplement Date Received by Manufacturer: 11/11/2020
• Initial Report FDA Received Date: 09/23/2020
• Supplement Report FDA Received Date: 11/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other