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

Model Number	386801
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	03/11/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that it was difficult to connect the infusion line, and then it disconnects after a time with a bd cathena¿ safety iv catheter.The following information was provided by the initial reporter, translated from (b)(6) to english: difficulty in connecting the 3-way tap infusion set and the bleeding set and untimely disconnection of the lines.The infusion line disconnects after a few hours.
Additional Manufacturer Narrative
H.6.Investigation: no photos or samples were received by our quality team for evaluation therefore the failure mode could not be verified.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.Based on the quality team's investigation, the root cause of this incident cannot be determined.
Event or Problem Description
It was reported that it was difficult to connect the infusion line, and then it disconnects after a time with a bd cathena¿ safety iv catheter.The following information was provided by the initial reporter, translated from french to english: difficulty in connecting the 3-way tap infusion set and the bleeding set and untimely disconnection of the lines.The infusion line disconnects after a few hours.

• Brand Name: BD CATHENA¿ SAFETY IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9907251
• Report Number: 8041187-2020-00185
• Device Sequence Number: 754659
• Product Code: FOZ
• UDI-Device Identifier: 00382903868018
• UDI-Public: 00382903868018
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: N/A
• 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): 06/01/2020

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 Expiration Date: 01/31/2022
• Device Model Number: 386801
• Device Catalogue Number: 386801
• Device Lot Number: 9021635
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 03/11/2020
• Supplement Date Received by Manufacturer: 03/11/2020
• Initial Report FDA Received Date: 03/31/2020
• Supplement Report FDA Received Date: 06/01/2020
• 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