MAUDE Adverse Event Report: BD (SUZHOU) UNSPECIFIED BD CATHETER; INTRAVASCULAR CATHETER

Catalog Number 383057

Device Problem Break (1069)

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

Event Date 10/16/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H3.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.H.4.Device manufacture date: unknown.

Event Description

It was reported an unspecified 18g intravenous catheters handle at the end of the needle core was broken.The following information was provided by the initial reporter, translated from chinese to english: (b)(6) 2023, an 18g intravenous indwelling needle was used to establish intravenous access for a patient.When the needle core was successfully removed through puncture, the handle at the end of the needle core was broken.After the needle core was pulled out, there was no abnormality in the normal saline prefill, and the examination was successfully completed.

Manufacturer Narrative

(b)(4) are duplicate complaints.Initial record was deemed to be not reportable.H3 other text : see narrative.

Event Description

(b)(4) are duplicate complaints.Initial record was deemed to be not reportable.

• Brand Name: UNSPECIFIED BD CATHETER
• 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: 18531419
• MDR Text Key: 333542754
• Report Number: 3014704491-2024-00010
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903830572
• UDI-Public: (01)00382903830572
• 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
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/11/2024

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: 383057
• Device Lot Number: 3136557
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/26/2023
• Initial Date FDA Received: 01/17/2024
• Supplement Dates Manufacturer Received: 04/11/2024
• Supplement Dates FDA Received: 04/16/2024
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/16/2023
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1