MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL (SINGAPORE) BD INSYTE BL 22GA X 1.0IN; INTRAVASCULAR CATHETER

Catalog Number 381223

Device Problems Leak/Splash (1354); Defective Component (2292)

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

Event Date 02/23/2022

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 when using the bd insyte bl 22ga x 1.0in, the device experienced leakage at the catheter and hub junction and the catheter adapter was defective.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "during the injection of the radioactive product, a leak was observed at the junction of the white catheter and blue base.The welding problem on the 2 parts of the catheter was observed three times on the same lot.

Manufacturer Narrative

H.6.Investigation: one photo was received by our quality team for evaluation.The photo was subjected to visual inspection to check for adapter and catheter tubing damage which could cause leakage.No obvious adapter and catheter tubing damage was observed in the photo.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.Based on the quality team's investigation, the root cause of this incident cannot be determined.

Event Description

It was reported when using the bd insyte bl 22ga x 1.0in, the device experienced leakage at the catheter and hub junction and the catheter adapter was defective.This event occurred 2 times.The following information was provided by the initial reporter.The customer stated: "during the injection of the radioactive product, a leak was observed at the junction of the white catheter and blue base.The welding problem on the 2 parts of the catheter was observed three times on the same lot.

Event Description

It was reported when using the bd insyte bl 22ga x 1.0in, the device experienced leakage at the catheter and hub junction and the catheter adapter was defective.Patient received medical intervention in the form of a second dose.The following information was provided by the initial reporter.The customer stated: "during the injection of the radioactive product, a leak was observed at the junction of the white catheter and blue base.The welding problem on the 2 parts of the catheter was observed three times on the same lot.Additional information: there was "injection on two occasions for the third patient.¿.

Manufacturer Narrative

The following fields were updated due to additional information: d9: device available for eval yes, d9: returned to manufacturer on: 07-jun-2022.H6: investigation summary two photos were received by our quality team for evaluation.The photos were subjected to visual inspection to check for adapter and catheter tubing damage which could cause leakage.No obvious adapter and catheter tubing damage were observed in the photo.Four boxes (b)(4) of representative samples with sealed packaging were also received by our quality team for evaluation.The samples were subjected to catheter leakage testing.All 191 samples passed the leak test.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.Based on the quality team's investigation, the root cause of this incident cannot be determined.

• Brand Name: BD INSYTE BL 22GA X 1.0IN
• 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: 13897254
• MDR Text Key: 288051370
• Report Number: 8041187-2022-00150
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903812233
• UDI-Public: 00382903812233
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K151698
• 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,Followup
• Report Date: 06/28/2022

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 Catalogue Number: 381223
• Device Lot Number: 1236545
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/28/2022
• Initial Date FDA Received: 03/25/2022
• Supplement Dates Manufacturer Received: 04/30/2022; 06/28/2022
• Supplement Dates FDA Received: 05/09/2022; 07/29/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/24/2021
• 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