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

Model Number	386803
Medical Device Problem Code	Failure to Deliver (2338)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/29/2023
Type of Reportable Event	Malfunction
Event or Problem 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.
Additional 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 or Problem 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.
Additional 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
• Common Device Name: 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
• Report Number: 8041187-2023-00177
• Device Sequence Number: 15200477
• Product Code: FOZ
• UDI-Device Identifier: 00382903868032
• UDI-Public: (01)00382903868032
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K172506
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 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
• Operator of Device: Other
• Device Expiration Date: 04/30/2025
• 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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/05/2023
• Supplement Date Received by Manufacturer: 05/09/2023
• Initial Report FDA Received Date: 04/26/2023
• Supplement Report FDA Received Date: 05/22/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/20/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown