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

Catalog Number	381123
Medical Device Problem Codes	Break (1069); Fluid/Blood Leak (1250)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion a supplemental report will be filed.
Event or Problem Description
It was reported that bd angiocath leaked at the catheter junction.The following information was provided by the initial reporter, translated from chinese to english: on (b)(6) 2023, patient underwent femoral head surface replacement in the operating room of our hospital.After the anesthesiologist placed the patient's tube, he found that the patient's indwelling needle had an obvious hematoma in the patient's body near the end of the needle.The anesthesiologist withdrew the needle and replaced it with a new one, which was then used normally without any adverse effects.The anesthesiologist examined the defective device postoperatively, and when he administered the fluid to the defective device, he found that the fluid was spilling out of the back of the needle, which meant that there was a break in the needle near the end of the indwelling needle, but the device was too small to be photographed clearly.The situation was so urgent during the procedure that the physician did not take a picture of the patient at the time of the adverse event.(there is nothing wrong with the attached picture, the syringe is for testing the leakage of the indwelling needle, the blue connector and the front hose are the part of the indwelling needle).
Additional Manufacturer Narrative
A device history record review was completed for provided material number 381123 and lot number 2027018.The review did not reveal any detected abnormalities during the production process that could have contributed to the reported defect and all quality tests were found to be within specification.To aid in the investigation of this issue, four (4) pictures were provided for evaluation by our quality team.Through examination of the pictures, a leak was observed; however, the exact location of the leak could not be determined.At this time, an exact cause could not be determined for this incident.Our quality team will continue to closely monitor the manufacturing process for signs of this potential defect and any emerging trends.

• 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: 18307539
• Report Number: 9610048-2023-00113
• Device Sequence Number: 6718396
• Product Code: FOZ
• UDI-Device Identifier: 30382903811237
• UDI-Public: (01)30382903811237
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/29/2023

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: 381123
• Device Lot Number: 2027018
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/17/2023
• Supplement Date Received by Manufacturer: 12/29/2023
• Initial Report FDA Received Date: 12/11/2023
• Supplement Report FDA Received Date: 12/29/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/09/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Sex: Unknown