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

Catalog Number	381147
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	06/22/2018
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 7173832; medical device expiration date: 2022-06-30; device manufacture date: 2017-07-12; medical device lot #: unknown; medical device expiration date: unknown; device manufacture date: unknown.A sample is available for evaluation.Upon completion of the investigation, a supplemental report will be filed.
Event or Problem Description
It was reported with the use of the bd angiocath¿ iv catheter there was an issue with foreign matter.There was no report of injury or further medical intervention.
Additional Manufacturer Narrative
Due to an it issue beginning on (b)(6) 2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: event attributed to: other.Device single use?: no.Device returned to manufacture: yes.
Event or Problem Description
It was reported with the use of the bd angiocath iv catheter there was an issue with foreign matter.There was no report of injury or further medical intervention.
Additional Manufacturer Narrative
One sample from each of the reported lot numbers was returned to flks for ftir analysis.As per request, all returned samples were examined an all exhibited clear droplets of material on the surface of the catheter.A small portion of this material was removed from a representative sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is silicone.A lot history review was carried out and no related non conformances were raised in association with this packaged lot concluding all inspections were performed per the applicable operations and met qc specifications.Investigation conclusion: based on the investigations conducted for complaints of excess silicone of angiocath, it has been found that the root cause of this on the catheter is caused by the excessive amount of silicone that is dispensed during the catheter siliconization process.
Event or Problem Description
It was reported with the use of the bd angiocath iv catheter there was an issue with foreign matter.There was no report of injury or further 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: 7694721
• Report Number: 9610048-2018-00094
• Device Sequence Number: 13636472
• Product Code: FOZ
• UDI-Device Identifier: 00382903811472
• UDI-Public: 00382903811472
• 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
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 10/08/2018

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 Catalogue Number: 381147
• Device Lot Number: SEE H.10
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/05/2018
• Initial Date Received by Manufacturer: 06/22/2018
• Supplement Date Received by Manufacturer: 06/22/2018; 06/22/2018
• Initial Report FDA Received Date: 07/17/2018
• Supplement Report FDA Received Date: 09/13/2018; 10/10/2018
• 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