MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH; PERIPHERAL IV CATHETERS

Catalog Number	381112
Medical Device Problem Code	Defective Component (2292)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/19/2024
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that bd angiocath has catheter tip damage.The following information was provided by the initial reporter, translated from japanese to english: it was reported that when tried to puncture the needle, the needle did not penetrate well, and the outer tube was bent.
Additional Manufacturer Narrative
H.3.A follow up mdr will be submitted if additional information, a device evaluation, or a device history review is completed.
Additional Manufacturer Narrative
To aid in the investigation of this issue, the affected sample was returned for evaluation by our quality team.Through examination of the sample, the catheter tip was observed damaged.The sample did not show any other abnormalities, and the cannula/bevel did not show any defects.A device history record review was completed for provided material number 381112 and lot number 4018877.The review did identify a record of bad catheter in the catheter pointing process which may be related to this reported incident.However, adjustments were made related to the catheter tip to improve the quality by the operators and preparers of the area according to procedures.These adjustments were evident during the review.Based on the investigation results, it is most likely that this incident resulted from the catheter pointing stage during production.According to the maintenance order, multiple actions were implemented to mitigate this defect.Corrective and preventive actions have been addressed for the defect of catheter tip damage.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.
Event or Problem Description
Additional information - 03-dec-2024: 1) did the needle appear dull/blunt? it is unknown 2) when referring to the ¿outer cylinder¿ and ¿outer tube¿ what component is that? is this the silicone catheter component or another component? the outer tube is a catheter.

• Brand Name: BD ANGIOCATH
• Common Device Name: PERIPHERAL IV CATHETERS
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; BR
• Manufacturer Contact: helen cox (mdr) ; 75 north fairway drive; vernon hills, IL 60061 ; 8473935694
• MDR Report Key: 20852546
• Report Number: 9610048-2024-00197
• Device Sequence Number: 20829245
• Product Code: FOZ
• UDI-Device Identifier: 00382903811120
• UDI-Public: (01)00382903811120(11)240221(17)290131(10)4018877
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/07/2025

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: Other
• Device Catalogue Number: 381112
• Device Lot Number: 4018877
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/20/2024
• Supplement Date Received by Manufacturer: 04/07/2025
• Initial Report FDA Received Date: 12/05/2024
• Supplement Report FDA Received Date: 04/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/21/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown