MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER WITH BD MULTIGUARD TECHNOLOGY; INTRAVASCULAR CATHETER

Model Number	386807
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	11/19/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.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 bd cathena¿ safety iv catheter with bd multiguard¿ technology had resistance when being advanced, and withdrawing it showed the tip had been split as the needle had pierced through it.The following information was provided by the initial reporter, translated from (b)(6) to english: "this is a report about a damaged catheter tip.After catheter/needle placement, the hcp felt resistance to advance the catheter/needle.The hcp then withdrew the catheter/needle and check them, and found that the catheter tip was split (damaged).".
Event or Problem Description
It was reported that the bd cathena¿ safety iv catheter with bd multiguard¿ technology had resistance when being advanced, and withdrawing it showed the tip had been split as the needle had pierced through it.The following information was provided by the initial reporter, translated from japanese to english: "this is a report about a damaged catheter tip.After catheter/needle placement, the hcp felt resistance to advance the catheter/needle.The hcp then withdrew the catheter/needle and check them, and found that the catheter tip was split (damaged).".
Additional Manufacturer Narrative
H6: investigation summary three pictures were received by our quality team for evaluation.From the photo, needle pieced through catheter was observed on the used sample.A device history record could not be evaluated as the lot number is unknown.The needle pieced through catheter could be due to product manipulation.This incident has been added to our database of reported incidents.H3 other text : see h.10.

• Brand Name: BD CATHENA SAFETY IV CATHETER WITH BD MULTIGUARD TECHNOLOGY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11060627
• Report Number: 8041187-2020-00858
• Device Sequence Number: 4241037
• Product Code: FOZ
• UDI-Device Identifier: 00382903868070
• UDI-Public: 00382903868070
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K201717
• 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): 01/25/2021

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: Health Professional
• Device Model Number: 386807
• Device Catalogue Number: 386807
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/30/2020
• Initial Date Received by Manufacturer: 11/24/2020
• Supplement Date Received by Manufacturer: 01/25/2021
• Initial Report FDA Received Date: 12/22/2020
• Supplement Report FDA Received Date: 02/02/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1