MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS BL 22GA X 1.00IN PRN-CAP Y; CATHETER

Catalog Number 383932

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Skin Inflammation (2443)

Event Date 09/10/2020

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.(b)(4).

Event Description

It was reported that pegasus bl 22ga x 1.00in prn-cap y was used on the patient, and phlebitis occurred.The following information was provided by the initial reporter: the patient had a pulmonary infection that required fluid infusion.After three days with this indwelling needle, the skin around the needle was red and swollen with tenderness.Then the doctor informed the nurse to stop infusion, pull out the intravenous indwelling needle, and treat the patient accordingly.On 2020/11/03, after discovering that the puncture site was infected, it was treated as phlebitis.There was no problem during the puncture process.Later, i communicated with the head nurse and learned that the phlebitis was caused by drugs.

Manufacturer Narrative

H6: investigation summary: a device history review was conducted for lot number 8253315.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.Additionally, a sample could not be obtained for evaluation and testing, but this lot was treated and received a certificate of conformance for sterility.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.

Event Description

It was reported that pegasus bl 22ga x 1.00in prn-cap y was used on the patient and phlebitis occurred.The following information was provided by the initial reporter: the patient had a pulmonary infection that required fluid infusion.After three days with this indwelling needle, the skin around the needle was red and swollen with tenderness.Then the doctor informed the nurse to stop infusion, pull out the intravenous indwelling needle, and treat the patient accordingly.(b)(6) 2020: after discovering that the puncture site was infected, it was treated as phlebitis.There was no problem during the puncture process.Later, i communicated with the head nurse and learned that the phlebitis was caused by drugs.

• Brand Name: PEGASUS BL 22GA X 1.00IN PRN-CAP Y
• Type of Device: CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 10849314
• MDR Text Key: 218642623
• Report Number: 3006948883-2020-00757
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: PENDING
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/16/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Expiration Date: 09/25/2021
• Device Catalogue Number: 383932
• Device Lot Number: 8253315
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/22/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other