MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD ANGIOCATH¿ IV CATHETER 20G X 1.16 IN; INTRAVASCULAR CATHETER

Catalog Number	381134
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/04/2017
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 foreign matter (particle) was found on the catheter of the bd angiocath¿ iv catheter 20g x 1.16 in, before use.There was no report of injury or medical intervention.
Additional Manufacturer Narrative
Investigation: samples/ photos: it was received one opened and unused sample returned from customer of batch: 3249332 from angiocath 20gx1.16.After visual analysis of the products under magnification, it was not possible to confirm the presence of silicone drops on the catheter.Dhr review: the batches of the packaged product 3249332 and the assembled set batch 3238050 referring to them were analyzed, but were no evidenced records of foreign/ no foreign matter in the product.Qn/ ncmr review: there are no quality notification (qn) or non-conformity report records of foreign and no foreign matter for the claimed lots.Based on the investigations the root cause was not determined for the reported incident, since the complaint was not confirmed.

• Brand Name: BD ANGIOCATH¿ IV CATHETER 20G X 1.16 IN
• 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: 6992058
• Report Number: 9610048-2017-00054
• Device Sequence Number: 1005063
• Product Code: FOZ
• UDI-Device Identifier: 00382903811342
• UDI-Public: 00382903811342
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• PMA/510(K) Number: K151698
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,other
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 12/20/2017

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: 09/30/2018
• Device Catalogue Number: 381134
• Device Lot Number: 3249332
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/26/2017
• Initial Date Received by Manufacturer: 10/06/2017
• Supplement Date Received by Manufacturer: 10/06/2017
• Initial Report FDA Received Date: 10/31/2017
• Supplement Report FDA Received Date: 12/20/2017
• 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