MAUDE Adverse Event Report: BECTON DICKINSON BD US CATHENA 20GX2.00IN STRAIGHT BC; INTRAVASCULAR CATHETER

Catalog Number	386864
Medical Device Problem Code	Material Twisted/Bent (2981)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/15/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 20gx2.00in straight bc catheter kink/bent it was reported by customer that ivs are too soft and twisting in pts vein.See attached report.Verbatim: complaint received via email(s) attached.Ivs are too soft and twisting in pts vein.See attached report.
Event or Problem Description
Material #: 386864; batch#: 3361269.It was reported by customer that ivs are too soft and twisting in pts vein.See attached report.Verbatim: complaint received via email(s) attached.Ivs are too soft and twisting in pts vein.See attached report.
Additional Manufacturer Narrative
Based on device history record review, no abnormality was observed during the production of the affected batches.On the returned used actual sample, observed catheter tubing slightly bent, no damage or uneven surface on tubing.The bent catheter tubing was most likely due to product application, as the sample was used.It was unlikely that the bent tubing was caused by assembly process, as it would cause cannula pierced through tubing if it occurred during assembly process.As the sample was used, actual root cause could not be determined.The nonconformance could have occurred out of the manufacturing facility during product application.As current control, there is an outgoing and in-process visual inspection to check for catheter tubing damage.

• Brand Name: BD US CATHENA 20GX2.00IN 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: 19498446
• Report Number: 2243072-2024-00688
• Device Sequence Number: 17807671
• Product Code: FOZ
• UDI-Device Identifier: 00382903868643
• UDI-Public: (01)00382903868643
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: K220584
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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: 386864
• Device Lot Number: 3361269
• 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: 05/15/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 06/10/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/27/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown