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

Catalog Number	386811
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/08/2024
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 cathena 20gx1.25in winged bc had foreign matter on the cannula the following information was provided by the initial reporter, translated from french to english: please find enclosed an adverse event report concerning the following dm: catheter bd catenary 20g it has been retained and is available for collection and analysis.When opening the catheter to infuse the patient and checking the equipment before pricking, a small piece of plastic piece of plastic ¿hanging¿ from the plastic cannula.
Event or Problem Description
Please find enclosed an adverse event report concerning the following dm: catheter bd catenary 20g.Ref 386811.Lot 2238458.It has been retained and is available for collection and analysis.When opening the catheter to infuse the patient and checking the equipment before pricking, a small piece of plastic piece of plastic ¿hanging¿ from the plastic cannula.
Additional Manufacturer Narrative
Our quality engineer inspected the photos and samples submitted for evaluation.The reported issue of foreign matter was not confirmed upon inspection of the samples.Analysis of the samples showed no foreign matter.However, a piece of soft, transparent, gel-like substance was found on the inner wall of the needle cover.Based on the soft gel-like texture and appearance, it is most likely a piece of solidified lubricant.During assembly process, silicone lubricant is applied on the cannula and catheter surface to reduce the needle penetration and catheter drag force during product insertion.It was most likely that excessive lubricant was applied onto the cannula or catheter surface and aggregated to form the solidified lubricant.Currently, the machine parameters for cannula and catheter lube dispensing amount are controlled and checked during every shift start up.Due to the extremely low occurrence rate for excessive lubricant complaints in the past 12 months, this is most likely an isolated case.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.Production records were reviewed, and this batch meets our manufacturing specification requirements.

• Brand Name: BD CATHENA 20GX1.25IN WINGED 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: 20869844
• Report Number: 2243072-2024-01204
• Device Sequence Number: 12909399
• Product Code: FOZ
• UDI-Device Identifier: 00382903868117
• UDI-Public: (01)00382903868117(11)220902(17)250831(10)2238458
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 01/15/2025

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 Expiration Date: 08/31/2025
• Device Catalogue Number: 386811
• Device Lot Number: 2238458
• 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: 11/14/2024
• Supplement Date Received by Manufacturer: 01/15/2025
• Initial Report FDA Received Date: 12/06/2024
• Supplement Report FDA Received Date: 01/15/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/02/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown