MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) SEE H.10.; INTRAVASCULAR CATHETER

Catalog Number 383734

Device Problems Break (1069); Leak/Splash (1354); Split (2537)

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

Event Date 03/04/2018

Event Type  malfunction  

Manufacturer Narrative

Medical device brand name: bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap).Medical device expiration date: unknown.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 during use of the bd pegasus¿ safety closed iv catheter system (y luer with bd q-syte ¿ luer access split septum and end cap ¿on the first day of infusion the nurse found the e-tubing broken and leaking of normal saline.¿ there was no report of injury or medical intervention.

Manufacturer Narrative

Investigation summary: a sample was received for the purpose of our investigation.The investigators were able to observe the reported failure mode in the sample provided.The sample was observed under a microscope, it had residual ex-tubing in the pp adapter and the section of the ex-tubing was broken and is not flat and coarse.The batch record was reviewed, no related abnormalities were found.Investigation conclusion: it was found that a misalignment in the pegasus semi-auto process can crush and pull the tubing to create the reported failure mode.Although the root cause for this issue is related to the manufacturing process it should be noted that the rate of occurrence for this event is extremely low.

• Brand Name: SEE H.10.
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 7334482
• MDR Text Key: 102340469
• Report Number: 8041187-2018-00065
• 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,health professional,o
• Type of Report: Initial,Followup
• Report Date: 03/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/13/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Nurse
• Device Catalogue Number: 383734
• Device Lot Number: 6035256
• Date Manufacturer Received: 03/04/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other