MAUDE Adverse Event Report: BECTON DICKINSON BD US CATHENA 20GX1.25IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386863
Medical Device Problem Code	Material Protrusion/Extrusion (2979)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/16/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd us cathena 20gx1.25in straight bc safety shield activation failed it was reported by customer that they have another failed sharp guard.It was told that the blue piece separates and the guard stays in the plastic housing.Verbatim: rcc received a complaint via email.Email(s) attached i have another failed sharp guard.I was told that the blue piece separates and the guard stays in the plastic housing.Lot 4116856.I have the product.Xxxxxxxxx xxxxxxxxxx ms rn npd-bc acns-bc clinical nurse specialist ed/trinity health grand rapids pronouns: she/her/hers xxxxxxxxxxxxxxxxxxxxxx.
Additional Manufacturer Narrative
If a device evaluation and/or device history review is completed, a supplemental report will be filed.
Event or Problem Description
Material #:386863; batch#:4116856.It was reported by customer that they have another failed sharp guard.It was told that the blue piece separates and the guard stays in the plastic housing.Verbatim: rcc received a complaint via email.I have another failed sharp guard.I was told that the blue piece separates and the guard stays in the plastic housing.Lot 4116856.I have the product.Ms rn npd-bc acns-bc.Clinical nurse specialist.(b)(6).Pronouns: she/her/hers.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batch.From the returned sample, observed that the safety mechanism was activated; no safety activation failure was observed.Hence, the reported defect was not observed.As current controls, there are daily outgoing and in-process functional test to check and detect safety activation failure.

• Brand Name: BD US CATHENA 20GX1.25IN STRAIGHT BC
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON; 1 becton drive; franklin lakes NJ 07417
• Manufacturer (Section G): BECTON DICKINSON MEDICAL (SINGAPORE); 30 tuas avenue 2; singapore NJ 07417
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20173975
• Report Number: 2243072-2024-00955
• Device Sequence Number: 20867610
• Product Code: FOZ
• UDI-Device Identifier: 00382903868636
• UDI-Public: (01)00382903868636(11)240505(17)270430(10)4116856
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 09/20/2024

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: Health Professional
• Device Catalogue Number: 386863
• Device Lot Number: 4116856
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/16/2024
• Supplement Date Received by Manufacturer: 09/20/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 09/20/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 05/05/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown