MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) 24G X 0.75IN (0.7 X 19 MM) INSYTE; INTERVASCULAR CATHETER

Catalog Number 381312

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

Patient Problem Complaint, Ill-Defined (2331)

Event Date 09/06/2019

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 has been reported that the 24g x 0.75in (0.7 x 19 mm) insyte has been found with the catheter separating from the hub during use.The following has been provided by the initial reporter: during induction, attempt to place a peripheral venous way in a patient with a 381312 catheter.At the opening of the packaging, the catheter is bowed.2nd opening, 1st infusion test, the catheter got disengaged from the needle.Clinical consequences: "patient asleep, but not infused.Risk in case of anesthetic complications.Delay in the progress of the operation.2 devices affected, one kept for expertise.

Manufacturer Narrative

H.6.Investigation summary: photo evaluation 2 photos were returned for evaluation.From the returned photos, it was unable to observe any non- conformance as the picture only show the batch number of the product.Sample evaluation sample was not decontaminated by vendor.1 actual sample with open packaging was returned for evaluation.The investigation was able to confirm what customer has experience as bent cannula was observed on the returned sample.Conclusion(s): bent cannula the nonconformance could have occurred due to the cannula gripper of the assembly process or during product application where the product is manipulated.However, there are no ring marks observed on the cannula of the returned sample.There is a sensor in the assembly process that which is able to detect the presence of cannula and will reject the part if the cannula is bent out of the sensor range.

Event Description

It has been reported that the 24g x 0.75in (0.7 x 19 mm) insyte has been found with the catheter separating from the hub during use.The following has been provided by the initial reporter: during induction, attempt to place a peripheral venous way in a patient with a 381312 catheter.At the opening of the packaging, the catheter is bowed.2nd opening, 1st infusion test, the catheter got disengaged from the needle.Clinical consequences : "patient asleep, but not infused.Risk ++ in case of anesthetic complications.Delay in the progress of the operation.» 2 devices affected, one kept for expertise.

• Brand Name: 24G X 0.75IN (0.7 X 19 MM) INSYTE
• Type of Device: INTERVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• MDR Report Key: 9118505
• MDR Text Key: 164276702
• Report Number: 8041187-2019-00761
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903813125
• UDI-Public: 30382903813125
• Combination Product (y/n): N
• PMA/PMN Number: K151698
• 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: 10/29/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 02/29/2024
• Device Catalogue Number: 381312
• Device Lot Number: 9054575
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 09/09/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 24 MO