MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM; INTERVASCULAR CATHETER

Catalog Number 383712

Device Problems Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944); Packaging Problem (3007)

Patient Problems No Patient Involvement (2645); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).

Event Description

It was reported that 10 bd pegasus¿ safety closed iv catheter systems experienced catheter damage/deformation and damaged or open unit seals/packaging where sterility was compromised.The following information was provided by the initial reporter: the teacher of the department opened the package and found that some indwelling needles were damaged, and some needles were exposed.At the same time, he found a box of needles with the same problem, which could not be used clinically.

Event Description

It was reported that 10 bd pegasus¿ safety closed iv catheter systems experienced catheter damage/deformation and damaged or open unit seals/packaging where sterility was compromised.The following information was provided by the initial reporter: the teacher of the department opened the package and found that some indwelling needles were damaged, and some needles were exposed.At the same time, he found a box of needles with the same problem, which could not be used clinically.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-02-22 h6: investigation summary a device history review was conducted for lot number 0055977.Our records show that this is the only instance of a 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, the sample submitted by the facility has been reviewed by our team of quality engineers.They noted that the breach in each package occurred at different locations and were not consistent.After conducting a thorough review of the manufacturing process our engineers were not able to identify a root cause that would associate this issue with the manufacturing or packaging processes.H3 other text : see h10.

• Brand Name: BD PEGASUS SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 11381335
• MDR Text Key: 234563845
• Report Number: 8041187-2021-00130
• 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: 04/20/2021

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: 02/28/2023
• Device Catalogue Number: 383712
• Device Lot Number: 0055977
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/22/2021
• Initial Date Manufacturer Received: 01/30/2021
• Initial Date FDA Received: 02/25/2021
• Supplement Dates Manufacturer Received: 04/20/2021
• Supplement Dates FDA Received: 05/03/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1