MAUDE Adverse Event Report: BD (SUZHOU) PEGASUS BL 22GAX1.00IN PRN-CAP Y NON-PVC; N/A

Catalog Number 383736

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

Patient Problem No Code Available (3191)

Event Date 03/31/2020

Event Type  Injury  

Manufacturer Narrative

A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported that pegasus bl 22gax1.00in prn-cap y non-pvc catheter separated during use.The following information was provided by the initial reporter: the cardiovascular and neurosurgery nurse found that the patient's indwelling needle was detached from the body at 3:30 on (b)(6) 2020.The indwelling needle catheter was lost.The patient had no self-consciousness and only his left arm could move.X-ray imaging of the upper body revealed no catheter in the body.No catheter was found outside the body.

Event Description

It was reported that pegasus bl 22gax1.00in prn-cap y non-pvc catheter separated during use.The following information was provided by the initial reporter: the cardiovascular and neurosurgery nurse found that the patient's indwelling needle was detached from the body at 3:30 on (b)(6) 2020.The indwelling needle catheter was lost.The patient had no self-consciousness and only his left arm could move.X-ray imaging of the upper body revealed no catheter in the body.No catheter was found outside the body.

Manufacturer Narrative

Investigation summary: a device history review was conducted for lot number 9168730.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.Although photos were submitted for evaluation, they did not display the failure mode clearly enough to identify the root cause.Functional testing was performed on the retention samples for the reported lot number.The results did not indicate the presence of any abnormalities in the tested units for pull force resistance.Unfortunately, without the ability to investigate the affected unit our quality engineers were unable to determine the root cause for this complaint.Bd will continue to monitor this issue.

• Brand Name: PEGASUS BL 22GAX1.00IN PRN-CAP Y NON-PVC
• Type of Device: N/A
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• MDR Report Key: 9981006
• MDR Text Key: 188672030
• Report Number: 3006948883-2020-00140
• 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: 04/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 07/31/2022
• Device Catalogue Number: 383736
• Device Lot Number: 9168730
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/31/2020
• Initial Date FDA Received: 04/21/2020
• Supplement Dates Manufacturer Received: 03/31/2020
• Supplement Dates FDA Received: 04/30/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention