MAUDE Adverse Event Report: BD (SUZHOU) BD US CATHENA 20GX1.25IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386863
Medical Device Problem Code	Activation Problem (4042)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/08/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
It was reported that bd us cathena 20gx1.25in straight bc safety shield activation failed the following information was provided by the initial reporter: it was reported by customer that attempted to place piv on patient.Had difficulty advancing needle.Once needle was advanced needle protector did not engage and needle was exposed.Verbatim: rcc received a complaint via email.Describe the event or problem: attempted to place piv on patient.Had difficulty advancing needle.Once needle was advanced needle protector did not engage and needle was exposed.Name: bd cathena safety iv catheter.
Event or Problem Description
Material #: 386863; batch#: 2215681.It was reported by customer that attempted to place piv on patient.Had difficulty advancing needle.Once needle was advanced needle protector did not engage and needle was exposed.Verbatim: rcc received a complaint via email.Email(s) attached.Describe the event or problem: attempted to place piv on patient.Had difficulty advancing needle.Once needle was advanced needle protector did not engage and needle was exposed.Model# 386863; lot# 2215681; name: bd cathena safety iv catheter.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.Needle penetration difficult / painful.As current control, there is a daily outgoing system penetration and catheter drag functional test that can detect cannula tip and catheter damage.There is also daily outgoing visual inspection to check for cannula tip and catheter damage and 2 hourly in-process visual inspection to check for catheter damage.As no photo/sample is returned for evaluation on the cannula tip and catheter condition, actual root cause could not be established.Safety shield activation failure (catheter).As current control, there is a daily outgoing functional test and 2-hourly in-process functional test to check and detect safety activation failure.As no photo/sample is returned for evaluation, actual root cause could not be established.The complaint will be re-opened and re-investigated when photo/sample is received.

• Brand Name: BD US CATHENA 20GX1.25IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BD (SUZHOU); no. 5 baiyu road; suzhou industrial park; suzhou
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 18422017
• Report Number: 3014704491-2023-00858
• Device Sequence Number: 18109639
• Product Code: FOZ
• UDI-Device Identifier: 00382903868636
• UDI-Public: (01)00382903868636
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/07/2024

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
• Operator of Device: Other
• Device Expiration Date: 07/31/2025
• Device Catalogue Number: 386863
• Device Lot Number: 2215681
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/05/2023
• Supplement Date Received by Manufacturer: 03/07/2024
• Initial Report FDA Received Date: 12/29/2023
• Supplement Report FDA Received Date: 03/07/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown