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

Catalog Number	381147
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	08/19/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bd angiocath¿ iv catheter had foreign matter.This occurred on 2 occasions before use.The following information was provided by the initial reporter: material no.381147, batch no.Unknown.It was reported 2 out of 66 catheters inspected were found that had some type of loose particulate.
Additional Manufacturer Narrative
H.6.Investigaton: bd was unable to perform a thorough investigation as no sample, lot, or batch number were provided.Dhr could not be performed as a result.The complaint is unconfirmed and the root cause is undetermined.H3 other text: see h.10.
Event or Problem Description
It was reported that bd angiocath¿ iv catheter had foreign matter.This occurred on 2 occasions before use.The following information was provided by the initial reporter: material no.381147; batch no.Unknown.It was reported 2 out of 66 catheters inspected were found that had some type of loose particulate.

• 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: 8967084
• Report Number: 9610048-2019-00275
• Device Sequence Number: 14172316
• Product Code: FOZ
• UDI-Device Identifier: 30382903811473
• UDI-Public: 30382903811473
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: K151698
• 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): 09/13/2019

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 Catalogue Number: 381147
• Device Lot Number: UNKNOWN
• Initial Date Received by Manufacturer: 08/19/2019
• Supplement Date Received by Manufacturer: 08/19/2019
• Initial Report FDA Received Date: 09/05/2019
• Supplement Report FDA Received Date: 09/13/2019
• 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