MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383714

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Itching Sensation (1943)

Event Date 03/29/2023

Event Type  malfunction  

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system broke/separated from the hub while the patient was asleep.The following information was provided by the initial reporter, translated from chinese: "when the nurse on night shift went to examine the patient, the patient and the nanny were in a state of quiet sleep at that time, and the patient¿s indwelling needle was exposed.It was found that the intravenous indwelling needle on the patient¿s right elbow had fallen off, and there was no local bleeding or ecchymosis, but the prolapsed indwelling needle tube the segment and the needle body have been completely separated.After comparing with the new indwelling needle of the same model, it is confirmed that it is complete.And leave evidence to report to the head nurse in the morning and confirm the completeness again.The patient's mind is clear, and sometimes there is a phenomenon of hand scratching.1.The hose of the indwelling needle fell off completely.2.From the time the catheter is placed until the nurse finds that the hose has fallen off, the retention time of the catheter is about 15 hours.The catheter was inserted around 8 o'clock in the morning, and the fluid was infused through the needle around 4 o'clock in the afternoon, which is still normal.".

Manufacturer Narrative

H.3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system broke/separated from the hub while the patient was asleep.The following information was provided by the initial reporter, translated from chinese: "when the nurse on night shift went to examine the patient, the patient and the nanny were in a state of quiet sleep at that time, and the patient¿s indwelling needle was exposed.It was found that the intravenous indwelling needle on the patient¿s right elbow had fallen off, and there was no local bleeding or ecchymosis, but the prolapsed indwelling needle tube the segment and the needle body have been completely separated.After comparing with the new indwelling needle of the same model, it is confirmed that it is complete.And leave evidence to report to the head nurse in the morning and confirm the completeness again.The patient's mind is clear, and sometimes there is a phenomenon of hand scratching.1.The hose of the indwelling needle fell off completely.2.From the time the catheter is placed until the nurse finds that the hose has fallen off, the retention time of the catheter is about 15 hours.The catheter was inserted around 8 o'clock in the morning, and the fluid was infused through the needle around 4 o'clock in the afternoon, which is still normal.".

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 2186505.Our records show that this is the only instance of this issue occurring in this production batch.According to the sampling plan applied for product performance, this lot was accepted and released without defects being noted during the final assembly or visual inspections.A sample could not be obtained for evaluation and testing; in lieu of the affected device, functional testing was performed on retention samples for this lot, the results of these show that the tested units performed within product specifications.Unfortunately without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• 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 ; 8448235433
• MDR Report Key: 16842396
• MDR Text Key: 314268705
• Report Number: 8041187-2023-00185
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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,Followup
• Report Date: 05/21/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: 383714
• Device Lot Number: 2186505
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/06/2023
• Initial Date FDA Received: 05/01/2023
• Supplement Dates Manufacturer Received: 05/21/2023
• Supplement Dates FDA Received: 06/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/05/2022
• 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