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

Catalog Number 383711

Device Problems Fluid/Blood Leak (1250); Hole In Material (1293)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/20/2017

Event Type  malfunction  

Manufacturer Narrative

Results: bd received one sample for investigation.Samples were decontaminated.A review of the device history record revealed no irregularities during the manufacture of the reported lot # 7017002.The returned material showed the reported defect.Upon visual examination, the extend tubing was found broken in the middle.The deformation looks to be caused by the slide clamp.The od and id thickness was measured and was found in uniformity of the extend tubing.Microscopic examination revealed no abnormality when measuring the part line flash dimension of the slide clamp.The defect may have been caused by the slide clamp design, the angle of the slide clamp or the material of the extend tubing.However, no abnormalities were found in any of the parameters of the returned sample.Therefore, a root cause cannot be finalized.

Event Description

It was reported that when a nurse performed a venipuncture on a patient using a bd pegasus¿ safety closed iv catheter system, the nurse found blood spilled as she opened the clip.As she pulled the device out, she found a hole on the tubing near the hub.There was no report of injury or medical intervention.

• Brand Name: BD PEGASUS¿ SAFETY CLOSED IV CATHETER SYSTEM
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 7154701
• MDR Text Key: 96227574
• Report Number: 8041187-2017-00274
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/12/2017

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: Nurse
• Device Expiration Date: 01/31/2020
• Device Catalogue Number: 383711
• Device Lot Number: 7017002
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/12/2017
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/06/2017
• Initial Date FDA Received: 12/29/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/27/2017
• 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
• Patient Outcome(s): Other