MAUDE Adverse Event Report: BD (SUZHOU) BD 9367879 INSYTE-A BL 22 GA X 1.5 IN; INTRAVASCULAR CATHETER

Catalog Number 382802

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

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

Event Date 11/24/2023

Event Type  malfunction  

Event Description

It was reported that bd 9367879 insyte-a bl 22 ga x 1.5 in had foreign matter the following information was provided by the initial reporter: this is a complaint about tip slightly bent.Customer reported that noticed small debris and bent tip before use.

Manufacturer Narrative

H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.

Manufacturer Narrative

1.Returned sample analysis: 1) due to the restrictions of the customs policy, the overseas samples cannot be returned to suzhou.Suzhou has received the returned photos.2) observed the returned photos, cannot observe the debris and the bent tip on the returned photos, refer to returned photos.9367879.Zip.2.Review batch record information: 1)complaint lot#2319927 was produced on insyte a assembly line ,produced in december 2022, packaging at m860 packing machine in december 2022, lot quantity is 10k.2)review the in-process test and outgoing test report for this lot product, all test results meet the product specifications, no abnormal for it.3)review the production record and machine troubleshooting records for this lot product, no abnormality, deviation or rework activities.3.Check the appearance of the retained sample.No abnormality was observed on the retained sample, attachment1- the picture of retained sample.4.Root cause: observed the returned photos, cannot observe the debris and the bent tip on the returned photos, the root cause cannot be confirmed.5.The plant continue pay attention to this defect.

Event Description

No additional information provided.

• Brand Name: BD 9367879 INSYTE-A BL 22 GA X 1.5 IN
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18415774
• MDR Text Key: 331609038
• Report Number: 3014704491-2023-00855
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/19/2024

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: 382802
• Device Lot Number: 2319927
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/07/2023
• Initial Date FDA Received: 12/28/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/31/2024
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1