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

Catalog Number 381237

Device Problem Contamination (1120)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 09/29/2022

Event Type  malfunction  

Manufacturer Narrative

Initial reporter e-mail: unknown.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 customer verbatim, the ¿transparent gel-like object¿ found on the needle tip could be the silicone lubricant on the cannula or catheter, which is intended to reduce cannula penetration and catheter drag force during product application.However, as no photo or sample was returned, the actual foreign matter type could not be confirmed, and the root cause could not be established.Examination of the product involved may provide clarification as to the cause for the reported failure.Complaints received for this product and condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that silicone was visible on the tip of the bd insyte¿ peripheral venous catheter needle while preparing to place it in the patient.The following information was provided by the initial reporter, translated from chinese: "on (b)(6) 2022 , the head nurse of the operating room was preparing to administer a disposable intravenous indwelling needle to a patient when she noticed a transparent gel-like object on the tip.".

• Brand Name: BD INSYTE¿ PERIPHERAL VENOUS CATHETER
• Type of Device: 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: 15676755
• MDR Text Key: 306517545
• Report Number: 8041187-2022-00617
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903812370
• UDI-Public: (01)00382903812370
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: K151698
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/24/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/26/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 381237
• Device Lot Number: 1298957
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/02/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/25/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1