MAUDE Adverse Event Report: BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD. BD PEGASUS PLUS¿ CLOSED NEEDLE PROTECTION IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383715

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

Patient Problems Inflammation (1932); Pain (1994); Swelling/ Edema (4577)

Event Date 06/28/2023

Event Type  Injury  

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 after use with bd pegasus plus¿ closed needle protection iv catheter system patient considered to have phlebitis within 48 hours of use.Hirudoid was applied.The following information was provided by the initial reporter, translated from chinese to english: the head nurse of the gynecology department reported that after the product was used by patients, bloodstream infections occurred and the same bacteria were detected and cultured.Due to the high frequency of occurrence, the hospital suspected that the product was contaminated by bacteria, and hoped that bd company could help it detect whether there was bacterial contamination in the product.Additional information received from the sales representative, and the description of the incident was updated as follows: this patient was considered to have phlebitis.The patient has redness, swelling, heat and pain at the puncture point, but no fever in the whole body; appear within 48 hours of catheterization; after the patient developed redness, swelling and heat pain, the indwelling needle was removed, and hirudoid was applied externally, and the patient's condition gradually eased; the indwelling needle is fully packaged before use.

Event Description

It was reported that after use with bd pegasus plus¿ closed needle protection iv catheter system patient considered to have phlebitis within 48 hours of use.Hirudoid was applied the following information was provided by the initial reporter, translated from chinese to english: the head nurse of the gynecology department reported that after the product was used by patients, bloodstream infections occurred and the same bacteria were detected and cultured.Due to the high frequency of occurrence, the hospital suspected that the product was contaminated by bacteria, and hoped that bd company could help it detect whether there was bacterial contamination in the product.Additional information received from the sales representative, and the description of the incident was updated as follows: this patient was considered to have phlebitis 1.The patient has redness, swelling, heat and pain at the puncture point, but no fever in the whole body; 2.Appear within 48 hours of catheterization; 3.After the patient developed redness, swelling and heat pain, the indwelling needle was removed, and hirudoid was applied externally, and the patient's condition gradually eased; 4.The indwelling needle is fully packaged before use.

Manufacturer Narrative

H.6.Investigation summary: in response to the event reported a device history review was conducted for lot number 2335073.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, used samples cannot be tested for biological contamination that occured prior to the opening of hte package.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.Bd will continue to monitor this issue.H3 other text : see h10.

• Brand Name: BD PEGASUS PLUS¿ CLOSED NEEDLE PROTECTION IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer (Section G): BD RAPIS DIAGNOSTICS (SUZHOU) CO. LTD.; 9 rui pu road export zone b; suzhou ; CH
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17368191
• MDR Text Key: 319479818
• Report Number: 3006948883-2023-00082
• 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: 08/04/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 383715
• Device Lot Number: 2335073
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/28/2023
• Initial Date FDA Received: 07/20/2023
• Supplement Dates Manufacturer Received: 08/04/2023
• Supplement Dates FDA Received: 08/22/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 12/01/2022
• 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
• Patient Outcome(s): Required Intervention