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

Model Number	381344
Medical Device Problem Codes	Leak/Splash (1354); Unstable (1667)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/28/2022
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.
Event or Problem Description
It was reported that the bd insyte-w¿ peripheral venous catheter leaked blood and backed out of the patient's vein.This occurred 50 times during use.The following information was provided by the initial reporter, translated from (b)(6): "blood leakage.Unfortunately, our customer told us that blood always leaked out and that it was not possible to fix the indwelling vein cannula properly to the patient." "what was the location of the leakage? the insertion site or elsewhere? ¿there is always leakage of blood from the cannula and it is not possible to fix it correctly on the patient¿ did the needle/catheter back out of vein? yes¿".
Event or Problem Description
It was reported that the bd insyte-w¿ peripheral venous catheter leaked blood and backed out of the patient's vein.This occurred 50 times during use.The following information was provided by the initial reporter, translated from german: "blood leakage.Unfortunately, our customer told us that blood always leaked out and that it was not possible to fix the indwelling vein cannula properly to the patient." "what was the location of the leakage? the insertion site or elsewhere? ¿there is always leakage of blood from the cannula and it is not possible to fix it correctly on the patient¿ did the needle/catheter back out of vein? yes.".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 18-apr-2022.H6: investigation summary: forty-nine unused representative samples were received for investigation.All representative samples were subjected to visual inspection to check for cannula and catheter tip integrity and penetration and drag testing to check for cannula and catheter penetration force and drag force.All samples passed the visual inspection with no cannula and catheter tip damage observed, and the penetration force and drag force were within product specification.The returned samples were also subjected to visual inspection to check for adapter and catheter tubing damage which could cause leakage as well as catheter leakage testing.No adapter and catheter tubing damage were observed, and all the samples passed the catheter leakage testing.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: BD INSYTE-W¿ PERIPHERAL VENOUS CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14162137
• Report Number: 8041187-2022-00207
• Device Sequence Number: 14935582
• Product Code: FOZ
• UDI-Device Identifier: 30382903813446
• UDI-Public: 30382903813446
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/20/2022

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: 09/30/2026
• Device Model Number: 381344
• Device Catalogue Number: 381344
• Device Lot Number: 1274065
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/29/2022
• Supplement Date Received by Manufacturer: 05/20/2022
• Initial Report FDA Received Date: 04/20/2022
• Supplement Report FDA Received Date: 06/03/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/01/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown