MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) PEGASUS YEL 24GA X 0.75IN PRN-CAP Y; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 383712

Device Problems Leak/Splash (1354); Difficult or Delayed Activation (2577)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/17/2020

Event Type  malfunction  

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 yel 24ga x 0.75in prn-cap y needle disengagement was difficult and the tubing clamp was defective.The following information was provided by the initial reporter: when using the pegasus, it was found that the heparin cap fell off, needle disengagement difficult, needle dull, pinch clamp can't be clamped which caused serious issue of blood return.The samples with problems cannot be returned because they have been used, and no photos have been provided.

Event Description

It was reported that pegasus yel 24ga x 0.75in prn-cap y needle disengagement was difficult and the tubing clamp was defective.The following information was provided by the initial reporter: 1.When using the pegasus, it was found that the heparin cap fell off, needle disengagement difficult, needle dull, pinch clamp can't be clamped which caused serious issue of blood return.2.The samples with problems cannot be returned because they have been used, and no photos have been provided.

Manufacturer Narrative

H.6.Investigation: a device history review was conducted for lot number 9201967.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.

• Brand Name: PEGASUS YEL 24GA X 0.75IN PRN-CAP Y
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 10827067
• MDR Text Key: 223636054
• Report Number: 8041187-2020-00729
• Device Sequence Number: 1
• Product Code: FPA
• 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: 01/12/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 383712
• Device Lot Number: 9201967
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1