MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC; CATHETER

Catalog Number 383716

Device Problem Leak/Splash (1354)

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

Event Date 09/30/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 24gax0.75in prn-capy non-pvc had connection issues and leaked.The following information was provided by the initial reporter: the patient was operated on (b)(6) 2021.The patient was given indwelling needle, the y-type connection site to access the connecta in the operating room.When the patient returned to the ward at 14:00 after surgery, the connecta was pre-removed, but it was found that the connection was too tight and could not be removed, so the connecta was not forcibly removed.During infusion of the patient, leakage were found at the y-type connector site due to broken, and could not be used, so the indwelling needle must be removed and the patient was given a second puncture indwelling needle.

Manufacturer Narrative

H6: investigation summary a device history review was conducted for lot number 1050699.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.See h10.

Event Description

It was reported that pegasus yel 24gax0.75in prn-capy non-pvc had connection issues and leaked.The following information was provided by the initial reporter: the patient was operated on (b)(6) 2021.The patient was given indwelling needle, the y-type connection site to access the connecta in the operating room.When the patient returned to the ward at 14:00 after surgery, the connecta was pre-removed, but it was found that the connection was too tight and could not be removed, so the connecta was not forcibly removed.During infusion of the patient, leakage were found at the y-type connector site due to broken, and could not be used, so the indwelling needle must be removed and the patient was given a second puncture indwelling needle.

• Brand Name: PEGASUS YEL 24GAX0.75IN PRN-CAPY NON-PVC
• Type of Device: 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: 12724947
• MDR Text Key: 282500020
• Report Number: 3014704491-2021-00234
• 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

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/28/2024
• Device Catalogue Number: 383716
• Device Lot Number: 1050699
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/02/2021
• Initial Date FDA Received: 10/30/2021
• Supplement Dates Manufacturer Received: 10/31/2021
• Supplement Dates FDA Received: 11/17/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/19/2021
• 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