MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS BL 22GA X 0.75IN PRN NON-PVC; INTERVASCULAR CATHETER

Catalog Number 383725

Device Problem Leak/Splash (1354)

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

Event Date 09/16/2021

Event Type  malfunction  

Event Description

It was reported when using the bd pegasus bl 22ga x 0.75in prn non-pvc there was leakage at the connection site.The following information was provided by the initial reporter.The customer stated: the patient was suffering from colon cancer.At 9:00 a.M.On (b)(6) 2021, the radiology nurse found blood oozing from the indwelling needle connector when placing the indwelling needle to draw blood before performing enhanced ct.When this situation was found, the nurse immediately removed the indwelling needle and performed hemostasis treatment in time.At the same time, no bleeding occurred after replacing the new indwelling needle.Ct was performed normally, presenting the patient with repeated puncture adverse events.The manufacturer has been informed to replace it.(b)(4).(b)(6) translation: the patient was diagnosed with colon cancer.At 9 am on (b)(6) 2021, the radiology nurse found that there was blood leaking from the indwelling needle joint when the indwelling needle was placed to draw back blood before performing enhanced ct on the patient.Upon discovering this situation, the nurse immediately removed the indwelling needle and performed hemostatic treatment in time.At the same time, after replacing the indwelling needle with a new one, there was no bleeding.Ct is performed normally, causing adverse events of repeated puncture to the patient.The manufacturer has been notified to replace it.(b)(4).

Manufacturer Narrative

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 when using the bd pegasus bl 22ga x 0.75in prn non-pvc there was leakage at the connection site.The following information was provided by the initial reporter.The customer stated: the patient was suffering from colon cancer.At 9:00 a.M.On (b)(6) 2021, the radiology nurse found blood oozing from the indwelling needle connector when placing the indwelling needle to draw blood before performing enhanced ct.When this situation was found, the nurse immediately removed the indwelling needle and performed hemostasis treatment in time.At the same time, no bleeding occurred after replacing the new indwelling needle.Ct was performed normally, presenting the patient with repeated puncture adverse events.The manufacturer has been informed to replace it.Adr# (b)(4).Googel translation the patient was diagnosed with colon cancer.At 9 am on (b)(6) 2021, the radiology nurse found that there was blood leaking from the indwelling needle joint when the indwelling needle was placed to draw back blood before performing enhanced ct on the patient.Upon discovering this situation, the nurse immediately removed the indwelling needle and performed hemostatic treatment in time.At the same time, after replacing the indwelling needle with a new one, there was no bleeding.Ct is performed normally, causing adverse events of repeated puncture to the patient.The manufacturer has been notified to replace it.Adr# (b)(4).

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 1110645.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.H3 other text : see h10.

• Brand Name: BD PEGASUS BL 22GA X 0.75IN PRN NON-PVC
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12929766
• MDR Text Key: 286367174
• Report Number: 3014704491-2021-00323
• 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: 12/20/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/03/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 383725
• Device Lot Number: 1110645
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/20/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/20/2021
• 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