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

Catalog Number 383734

Device Problem Leak/Splash (1354)

Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/02/2021

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 the bd pegasus¿ safety closed iv catheter system experienced tubing separation from adapter/luer connector.The following information was provided by the initial reporter: on the morning of (b)(6) 2021, after the indwelling needle was inserted into the patient, the extension tube was broken at the junction of y shape joint, and saline water flowed out of the rupture, leading to the removal of the indwelling needle and the need to re-insert the needle.

Event Description

It was reported that the bd pegasus¿ safety closed iv catheter system experienced tubing separation from adapter/luer connector.The following information was provided by the initial reporter: on the morning of (b)(6) 2021, after the indwelling needle was inserted into the patient, the extension tube was broken at the junction of y shape joint, and saline water flowed out of the rupture, leading to the removal of the indwelling needle and the need to re-insert the needle.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-03-04 h6: investigation summary a device history review was conducted for lot number 0197309.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, the sample provided by the facility was reviewed by our team of quality engineers, they were able to locate the reported tear in the device¿s tubing a formulated several potential hypotheses as what could have caused this event.After reviewing and testing both the manufacturing line and the packaging process, our engineers were unable to replicate the tear in the tubing.Retention sample were exposed to functional testing in attempts to detect additional instances of this non-conformance, and the results of these tests found the retained samples to be free of any abnormalities or defects.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: 11386794
• MDR Text Key: 233817909
• Report Number: 8041187-2021-00135
• 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: 04/06/2021

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: 07/31/2023
• Device Catalogue Number: 383734
• Device Lot Number: 0197309
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/04/2021
• Initial Date Manufacturer Received: 02/02/2021
• Initial Date FDA Received: 02/26/2021
• Supplement Dates Manufacturer Received: 04/06/2021
• Supplement Dates FDA Received: 04/13/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1