MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE-W IV CATHETER; INTRAVASCULAR CATHETER

Catalog Number	381357
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Blood Loss (2597)
Date of Event	10/28/2020
Type of Reportable Event	Malfunction
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 the bd insyte-w¿ iv catheter experienced leakage.The following information was provided by the initial reporter: after cesarean section, the second vein channel was established according to the doctor's advice.After successful puncture, there was leakage of blood, the needle core was pulled out and connected to the infusion set.After observation, no extravasation was found, the patient continued to use the vein.
Additional Manufacturer Narrative
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 the bd insyte-w¿ iv catheter experienced leakage.The following information was provided by the initial reporter: after cesarean section, the second vein channel was established according to the doctor's advice.After successful puncture, there was leakage of blood, the needle core was pulled out and connected to the infusion set.After observation, no extravasation was found, the patient continued to use the vein.

• Brand Name: BD INSYTE-W IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10933097
• Report Number: 8041187-2020-00792
• Device Sequence Number: 14111288
• Product Code: FOZ
• UDI-Device Identifier: 00382903813575
• UDI-Public: 00382903813575
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• 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): 12/16/2020

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: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 381357
• Device Lot Number: 7201155
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 11/06/2020
• Supplement Date Received by Manufacturer: 12/16/2020
• Initial Report FDA Received Date: 12/02/2020
• Supplement Report FDA Received Date: 01/04/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1