MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM; INTRAVASCULAR CATHETER

Catalog Number 383914

Device Problems Fluid/Blood Leak (1250); Defective Component (2292)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 03/28/2022

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 6 bd pegasus¿ safety closed iv catheter systems' had damaged tubing and liquid leaked from them during use.The following information was provided by the initial reporter, translated from (b)(6) : "the head nurse found the leakage from the catheter tube when using the product" "there is liquid leakage at the catheter tubing, the catheter tubing was damaged, there was no catheter tubing breakage, and the abnormal product has been returned.".

Manufacturer Narrative

The following fields were updated due to additional information: d.9.Device available for eval?: yes d.9.Returned to manufacturer on: 18-apr-2022 h.6.Investigation: a device history review was conducted for lot number 1229796.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 several samples were submitted to aid in our investigation.Our engineers were able to identify damage along catheter tubing that is consistent with a needle puncture.Needle punctures that are generated during the manufacturing process will lead to an inoperable device.It is possible that during use the device maybe partially retracted by the operator which can lead to puncture of and leakage through the catheter tubing.Based on the available observation our engineers were unable to associate this failure mode with the manufacturing process.H3 other text : see h.10.

Event Description

It was reported that 6 bd pegasus¿ safety closed iv catheter systems' had damaged tubing and liquid leaked from them during use.The following information was provided by the initial reporter, translated from chinese: "the head nurse found the leakage from the catheter tube when using the product" "there is liquid leakage at the catheter tubing, the catheter tubing was damaged, there was no catheter tubing breakage, and the abnormal product has been returned.".

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer (Section G): BECTON DICKINSON MEDICAL DEVICES CO., LTD. SUZHOU; no.1 liangpu street; suzhou industrial park; suzhou 21512 6; CH 215126
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 14148257
• MDR Text Key: 290157197
• Report Number: 3014704491-2022-00150
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/25/2022

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: Health Professional
• Device Catalogue Number: 383914
• Device Lot Number: 1229796
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/19/2022
• Supplement Dates Manufacturer Received: 05/25/2022
• Supplement Dates FDA Received: 06/17/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/17/2021
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1