MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS BL 22GA X 0.75IN PRN NON-PVC; INTRAVASCULAR ADMINISTRATION SET

Catalog Number 383725

Device Problem Difficult or Delayed Activation (2577)

Patient Problem Blood Loss (2597)

Event Date 09/26/2019

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.

Event Description

It was reported that leakage occurred during use with a pegasus bl 22ga x 0.75in prn non-pvc.The following information was provided by the initial reporter, "one 22ga pegasus was noticed that catheter detached from the catheter adapter and result in blood leakage during penetration around 13:50 p.M.Of (b)(6) 2019.Qty of leaked blood waiting for the confirmation from sales rep.One 22ga pegasus was noticed that needle disengagement difficult around 15:11 p.M.Of (b)(6) 2019.One 22ga pegasus was noticed that needle disengagement difficult around 16:10 p.M.Of (b)(6) 2019".3 occurrences were reported.

Event Description

It was reported that leakage occurred during use with a pegasus bl 22ga x 0.75in prn non-pvc.The following information was provided by the initial reporter, "one 22ga pegasus was noticed that catheter detached from the catheter adapter and result in blood leakage during penetration around 13:50 p.M.Of (b)(6) 2019 qty of leaked blood waiting for the confirmation from sales rep.One 22ga pegasus was noticed that needle disengagement difficult around 15:11 p.M.Of (b)(6) 2019.One 22ga pegasus was noticed that needle disengagement difficult around 16:10 p.M.Of (b)(6) 2019" 3 occurrences were reported.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 9050942.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.Through visual evaluation of the submitted devices our engineers were able to identify damage in the component tip shield.The root cause for this occurrence is most likely due to a missing pin in the manufacturing machinery that lead to a misalignment during assembly.To address this issue we have repaired the damaged equipment, and retrained our inspection teams to increase awareness of this defect.

• Brand Name: PEGASUS BL 22GA X 0.75IN PRN NON-PVC
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9188512
• MDR Text Key: 179487244
• Report Number: 3006948883-2019-00863
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• 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: 11/05/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/14/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 03/26/2022
• Device Catalogue Number: 383725
• Device Lot Number: 9050942
• Date Manufacturer Received: 09/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other