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

Model Number	386811
Medical Device Problem Codes	Break (1069); Leak/Splash (1354)
Health Effect - Clinical Code	Foreign Body In Patient (2687)
Date of Event	10/29/2020
Type of Reportable Event	Serious Injury
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 when the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology was removed from the patient, the end of the catheter broke off and remained in the vein.An incision was performed by a hand surgeon to remove the broken piece, and an echo-doppler was performed the day after the incident.No further complications were revealed.The following information was provided by the initial reporter, translated from (b)(6) to english: when a 20g peripheral catheter was placed in a sepsis patient, the catheter could not be mounted, so it was removed.When the catheter was removed, a resistance appeared and one end of the plastic of the catheter was cut and remained in the vein.Clinical consequences observed: incision in the chamber to retrieve the foreign material on a septic patient.Update november 6: indeed the catheter did come into contact with blood and chemotherapy products because the incident occurred during the patient's chemo treatment.Concerning the consequences, according to the file a hand surgeon had to intervene to remove the piece that remained in the patient, an echo-doppler was performed the day after the incident (30/10), which did not reveal any deep vein thrombosis.
Additional Manufacturer Narrative
H6: investigation summary: 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 when the bd cathena¿ safety iv catheter with wings bd multiguard¿ technology was removed from the patient, the end of the catheter broke off and remained in the vein.An incision was performed by a hand surgeon to remove the broken piece, and an echodoppler was performed the day after the incident.No further complications were revealed.The following information was provided by the initial reporter, translated from french to english: "when a 20g peripheral catheter was placed in a sepsis patient, the catheter could not be mounted, so it was removed.When the catheter was removed, a resistance appeared and one end of the plastic of the catheter was cut and remained in the vein.Clinical consequences observed: incision in the chamber to retrieve the foreign material on a septic patient.".

• Brand Name: BD CATHENA SAFETY IV CATHETER WITH WINGS BD MULTIGUARD TECHNOLOGY
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10909837
• Report Number: 8041187-2020-00783
• Device Sequence Number: 3043738
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: 00382903868117
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• 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): 12/14/2020

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: Health Professional
• Device Expiration Date: 01/31/2023
• Device Model Number: 386811
• Device Catalogue Number: 386811
• Device Lot Number: 0037969
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/02/2020
• Supplement Date Received by Manufacturer: 12/14/2020
• Initial Report FDA Received Date: 11/26/2020
• Supplement Report FDA Received Date: 12/31/2020
• 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: Required Intervention