MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER; INTRAVASCULAR CATHETER

Model Number	381134
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	04/01/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
"multiple lot numbers: there were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 8029834, medical device expiration date: 2023-01-31, device manufacture date: 2018-02-09, medical device lot #: 9115742, medical device expiration date: 2024-04-30, device manufacture date: 2019-05-08".A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that foreign matter was discovered on catheter with a bd angiocath¿ iv catheter.This occurred on 3 separate occasions prior to use with both lots.The following information was provided by the initial reporter: it was reported that there are some white droplet particles on the catheter.
Event or Problem Description
It was reported that foreign matter was discovered on catheter with a bd angiocath¿ iv catheter.This occurred on 3 separate occasions prior to use with both lots.The following information was provided by the initial reporter: it was reported that there are some white droplet particles on the catheter.
Additional Manufacturer Narrative
H.6.Investigation: bd received six unused 20 gauge angiocath units.Three units were from lot 8029834 and three units were from lot 9115742.A review of the device history record was performed for both lots and no quality issues were found during production.Our quality engineer visually inspected the returned units and observed no foreign matter present on the returned units.However, after reviewing the provided photos the engineer was able to identify silicone on the catheter pictured.Based off the provided photo the engineer was able to verify the reported defect.Please note, though, that silicone is used during the manufacturing process and would not affect the form, fit or function of the device.It has been tested and was determined to not cause harm to the user but only to reduce the resistance felt during venipuncture.The excess silicone most likely came from the siliconization of the catheter during the assembly process.

• Brand Name: BD ANGIOCATH¿ IV CATHETER
• Common Device Name: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• MDR Report Key: 10012356
• Report Number: 9610048-2020-00065
• Device Sequence Number: 11553271
• Product Code: FOZ
• UDI-Device Identifier: 30382903811343
• UDI-Public: 30382903811343
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: N/A
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 05/13/2020

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 Model Number: 381134
• Device Catalogue Number: 381134
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/23/2020
• Initial Date Received by Manufacturer: 04/09/2020
• Supplement Date Received by Manufacturer: 04/09/2020
• Initial Report FDA Received Date: 04/29/2020
• Supplement Report FDA Received Date: 05/13/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other