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	07/31/2018
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 #: 7270758; medical device expiration date: 2022-09-30; device manufacture date: 2017-10-27; medical device lot #: 7173832; medical device expiration date: 2022-06-30; device manufacture date: 2017-07-12.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¿ iv catheter had foreign matter described as "water like" and "sticky" on the catheter.No serious injury or medical intervention was reported.
Event or Problem Description
It was reported that bd angiocath iv catheter had foreign matter described as "water like" and "sticky" on the catheter.No serious injury or medical intervention was reported.
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.As per request, (10) samples were randomly selected from each reported lot number and examined.All examined samples from each of the lot numbers exhibited clear droplets of material on the surface of the catheter.One representative sample from each of the reported lot numbers was selected and a small amount of the material was removed from each sample and prepared for ftir spectral analysis.The spectral analysis shows that this material is silicone for each of the lot numbers.A review of the device history record was completed for the lots 7270758, 7173832 regarding tests to verify "foreign matter/visible silicone" and no records were found that could lead to the claimed defect.Confirmed: bd was able to confirm the customer complaint for the claimed defect.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.(b)(4) has been initiated for this issue.

• 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: 7789786
• Report Number: 9610048-2018-00112
• Device Sequence Number: 19225861
• 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
• Report Date (Section B): 09/07/2018

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: 08/10/2018
• Initial Date Received by Manufacturer: 07/31/2018
• Supplement Date Received by Manufacturer: 07/31/2018
• Initial Report FDA Received Date: 08/16/2018
• Supplement Report FDA Received Date: 10/25/2018
• 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