MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD CATHENA SAFETY IV CATHETER; INTRAVASCULAR CATHETER

Model Number 386803

Device Problem Failure to Deliver (2338)

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

Event Date 03/29/2023

Event Type  malfunction  

Event Description

It was reported while using bd cathena safety iv catheter there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: on (b)(6), rn reported that twice on their shift there was a malfunction in the iv catheter.The catheter was inserted and blood return flow was observed and needle was removed.Once the catheter was attached to the iv tubings and started infusion, there was resistance.Iv was disconnected and syringe was used in attempt to test whether there was resistance.Iv was removed subsequently and resited.Another incident experienced by another nurse with a different lot number with similar incident.The latter eventually worked.One other incident reported by dr.In or.Similar incident, resistant.It appears on all the incidents that the spring malfunction inside the iv catheter.The above incidents happened sporadically using the same lot numbers on (b)(6).Stores was consulted but no other available lot number.

Manufacturer Narrative

H.3.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 while using bd cathena safety iv catheter there was a blockage.There was no report of patient impact.The following information was provided by the initial reporter: on march 29, rn reported that twice on their shift there was a malfunction in the iv catheter.The catheter was inserted and blood return flow was observed and needle was removed.Once the catheter was attached to the iv tubings and started infusion, there was resistance.Iv was disconnected and syringe was used in attempt to test whether there was resistance.Iv was removed subsequently and resited.Another incident experienced by another nurse with a different lot number with similar incident.The latter eventually worked.One other incident reported by dr.In or.Similar incident, resistant.It appears on all the incidents that the spring malfunction inside the iv catheter.The above incidents happened sporadically using the same lot numbers on march 28 & 29.Stores was consulted but no other available lot number.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 26-apr-2023 investigation summary: our quality engineer inspected the 1 representative sample from batch 2110442 submitted for evaluation.The reported issue of flow rate slow / occluded was not confirmed upon inspection and testing of the sample.Analysis of the sample showed that there was no damages or abnormalities present.The sample was functionally tested and performed as designed with no failures observed.Bd cannot determine a manufacturing related root cause since the reported defect was not confirmed during the representative sample evaluation.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD CATHENA SAFETY IV CATHETER
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16820915
• MDR Text Key: 314083504
• Report Number: 8041187-2023-00177
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: (01)00382903868032
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K172506
• 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: 04/29/2023

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: Other
• Device Model Number: 386803
• Device Catalogue Number: 386803
• Device Lot Number: 2110442
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 04/05/2023
• Initial Date FDA Received: 04/26/2023
• Supplement Dates Manufacturer Received: 05/09/2023
• Supplement Dates FDA Received: 05/22/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/20/2022
• 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