MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE¿ IV CATHETER 20GA 1.88IN; INTRAVASCULAR CATHETER

Model Number 381237

Device Problem Device Contamination with Chemical or Other Material (2944)

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

Event Date 03/09/2022

Event Type  malfunction  

Manufacturer Narrative

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 while using bd insyte¿ iv catheter 20ga 1.88in foreign matter was found on the needle.There was no report of patient impact.The following information was provided by the initial reporter: on (b)(6) 2022, the indwelling needle was examined before the intravenous access was opened for the patient.Foreign bodies were found between the catheter tube and the inner core of the indwelling needle, so the use was stopped and the indwelling needle was replaced without any impact on the patient.

Manufacturer Narrative

H.6.Investigation: two photos were received by our quality team for evaluation.The photos were subjected to visual inspection to check for foreign matter.A piece of loose fm was observed on the cannula tip.However, the foreign matter photo, taken with the needle cover on, was too blurry for evaluation.A review of the internal manufacturing device records and raw material history files for the reported lot number was performed and no recorded quality problems or rejections to this incident were found.As the actual sample was not returned to be subjected to fourier transform infrared spectroscopy (ftir) analysis in order to identify the foreign matter material, the actual root cause could not be established.

Event Description

It was reported while using bd insyte¿ iv catheter 20ga 1.88in foreign matter was found on the needle.There was no report of patient impact.The following information was provided by the initial reporter: on (b)(6) 2022, the indwelling needle was examined before the intravenous access was opened for the patient.Foreign bodies were found between the catheter tube and the inner core of the indwelling needle, so the use was stopped and the indwelling needle was replaced without any impact on the patient.

• Brand Name: BD INSYTE¿ IV CATHETER 20GA 1.88IN
• 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 ; 8015296192
• MDR Report Key: 13965172
• MDR Text Key: 288707604
• Report Number: 8041187-2022-00157
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903812371
• UDI-Public: 30382903812371
• Combination Product (y/n): N
• Reporter Country Code: CH
• PMA/PMN Number: NA
• 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: 04/07/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 381237
• Device Catalogue Number: 381237
• Device Lot Number: 1274229
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/01/2021
• 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