MAUDE Adverse Event Report: BECTON DICKINSON BD PEGASUS PNK 20GA X 1.16IN PRN-CAP Y; INTRAVASCULAR CATHETER

Catalog Number 383742

Device Problem Difficult or Delayed Activation (2577)

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

Event Date 01/30/2024

Event Type  malfunction  

Event Description

It was reported that bd pegasus pnk 20ga x 1.16in prn-cap y needle disengagement was difficult the following information was provided by the initial reporter: needle core cannot be withdrawn.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

This complaint is duplicate of (b)(4).Related mdr is recorded under (b)(4).

Event Description

This complaint is duplicate of (b)(4).Related mdr is recorded under (b)(4).

• Brand Name: BD PEGASUS PNK 20GA X 1.16IN PRN-CAP Y
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18780637
• MDR Text Key: 336317275
• Report Number: 2243072-2024-00208
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903837427
• UDI-Public: (01)00382903837427
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: UNK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 02/28/2024

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 Catalogue Number: 383742
• Device Lot Number: 3186537
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/02/2024
• Initial Date FDA Received: 02/26/2024
• Supplement Dates Manufacturer Received: 02/28/2024
• Supplement Dates FDA Received: 03/05/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/10/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1