MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEGASUS YEL 24GA X 0.75IN PRN; CATHETER

Catalog Number 383711

Device Problem Leak/Splash (1354)

Patient Problems Pain (1994); Fluid Discharge (2686); Swelling/ Edema (4577)

Event Date 09/07/2021

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that pegasus yel 24ga x 0.75in prn leaked.The following information was provided by the initial reporter: at 14:00, on 09-07, the responsible nurse changed the fluid refill, inspected the patient's skin, found the patient's right hand vein indwelling needle exudate, immediately reported to the doctor, gave external smear hirudoid, oral cephalosporin antibiotic treatment.Report to the head nurse, elevate the affected limb and apply local hot compress to promote inflammation absorption and pain relief.Report the adverse events of instrument injury.

Event Description

It was reported that pegasus yel 24ga x 0.75in prn leaked.The following information was provided by the initial reporter: at 14:00, on 09-07, the responsible nurse changed the fluid refill, inspected the patient's skin, found the patient's right hand vein indwelling needle exudate, immediately reported to the doctor, gave external smear hirudoid, oral cephalosporin antibiotic treatment.Report to the head nurse, elevate the affected limb and apply local hot compress to promote inflammation absorption and pain relief.Report the adverse events of instrument injury.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 0323775.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: PEGASUS YEL 24GA X 0.75IN PRN
• Type of Device: 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: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12689497
• MDR Text Key: 278141534
• Report Number: 8041187-2021-00921
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: PENDING
• 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: 10/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/25/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 10/31/2023
• Device Catalogue Number: 383711
• Device Lot Number: 0323775
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 10/31/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/18/2020
• 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
• Patient Outcome(s): Required Intervention