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

Catalog Number	381134
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	09/26/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.(b)(6).A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported that water drop-like foreign matter was found on the bd angiocath¿ iv catheter.There was no report of exposure, injury, or medical intervention.
Additional Manufacturer Narrative
Bd was able to verify the presence of silicone drops on the catheter of the returned samples.It should be noted that this silicone does not cause damage to the user and is used to aid in the slippage of the catheter during venipuncture.The root cause of this on the catheter is caused by the excessive amount of silicone that is dispensed during the catheter siliconization process.Dhr review: a review of the device history record was completed for (b)(4), lot 4300253 manufactured from 06-nov-14 to 10-nov-14 in acam04 machine used in claimed lot 4310397.This lot was reviewed regarding the tests of ¿foreign matter/visible silicone¿ and were not evidenced records that could lead to the claimed defect.Qn/ ncmr review: there are no quality notification (qn) or nonconformity report of ¿foreign matter/visible silicone¿ or anything that could lead to this complaint.Unplanned maintenance: the corrective maintenance history in the manufacturing period of the assembly lot involved in this complaint was evaluated and no records were found related to this issue.A corrective action project has been initiated to investigate the issue.(b)(4).
Event or Problem Description
It was reported that water drop-like foreign matter was found on the bd angiocath iv catheter.There was no report of exposure, injury, or medical intervention.

• 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: 7975013
• Report Number: 9610048-2018-00159
• Device Sequence Number: 19115617
• Product Code: FOZ
• UDI-Device Identifier: 30382903811343
• UDI-Public: 30382903811343
• 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,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 10/29/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Expiration Date: 11/30/2019
• Device Catalogue Number: 381134
• Device Lot Number: 4310397
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/09/2018
• Initial Date Received by Manufacturer: 09/26/2018
• Supplement Date Received by Manufacturer: 09/26/2018
• Initial Report FDA Received Date: 10/17/2018
• Supplement Report FDA Received Date: 10/29/2018
• 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