MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) CATHENA 20GX1.00IN STRAIGHT BC; IV CATHETER

Catalog Number	386803
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	05/02/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Device expiration date: unknown.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the cathena 20gx1.00in straight bc experienced needle breakage.The following information was provided by the initial reporter; staff member was prepping to cannulate & noticed it looked odd.The very tip of the cannula came off when she removed the stylet.The piece is only a fraction of a millimeter.It may still be in the packaging.
Additional Manufacturer Narrative
Investigation: since no batch number, samples or photos displaying the condition reported are available for examination, we were unable to fully investigate this incident.Dhr could not be performed due to unknown lot#.Complaint was not confirmed and root cause undetermined.
Event or Problem Description
It was reported that the cathena 20gx1.00in straight bc experienced needle breakage.The following information was provided by the initial reporter; staff member was prepping to cannulate & noticed it looked odd.The very tip of the cannula came off when she removed the stylet.The piece is only a fraction of a millimeter.It may still be in the packaging.

• Brand Name: CATHENA 20GX1.00IN STRAIGHT BC
• Common Device Name: IV CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 8616911
• Report Number: 8041187-2019-00381
• Device Sequence Number: 2182547
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: 00382903868032
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,health professional,o
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 06/21/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: 386803
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 05/02/2019
• Supplement Date Received by Manufacturer: 05/02/2019
• Initial Report FDA Received Date: 05/16/2019
• Supplement Report FDA Received Date: 06/24/2019
• 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