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

Model Number	386803
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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 9050983.Medical device expiration date: 2022-02-28.Device manufacture date: 2019-02-19.Medical device lot #: 9021623.Medical device expiration date: 2022-01-31.Device manufacture date: 2019-01-21.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 a connection issue occurred with a cathena 20gx1.00in straight bc.The following information was provided by the initial reporter, "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.The bleeding tubing: impossible to perform the bleeding, were forced to perform the bleeding from a syringe.".
Event or Problem Description
It was reported that a connection issue occurred with a cathena 20gx1.00in straight bc.The following information was provided by the initial reporter, "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.The bleeding tubing: impossible to perform the bleeding, were forced to perform the bleeding from a syringe.".
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.

• Brand Name: CATHENA 20GX1.00IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9908153
• Report Number: 8041187-2020-00188
• Device Sequence Number: 13972348
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: 00382903868032
• 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): 05/11/2020

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 Model Number: 386803
• Device Catalogue Number: 386803
• Device Lot Number: SEE. H.10
• 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: 05/11/2020
• 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