MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. 18G X 1.88IN (1.3 X 48 MM) ANGIOCATH; INTRAVASCULAR CATHETER

Catalog Number	381147
Medical Device Problem Codes	Leak/Splash (1354); Loose or Intermittent Connection (1371)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	10/30/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 has been reported that one 18g x 1.88in (1.3 x 48 mm) angiocath has been found with a loose needle before use.The following has been provided by the initial reporter: on (b)(6) 2019, medical staff found that the angiocath's needle pulled out of hub during pre-use examination.
Additional Manufacturer Narrative
H.6.Investigation summary: bd received an 18 gauge angiocath unit from lot 8180804 for evaluation.A review of the device history record was performed for the reported lot and no quality issues were found during production.Our quality engineer visually inspected the returned unit and observed that the needle was loose from the hub.There was no glue on the hub or at the end of the needle.Based off the visual inspection the engineer was able to verify the reported defect.This was determined to have been a manufacturing defect.It most likely occurred during the glue application station failing to apply sufficient amounts of adhesive to the unit.The manufacturing facility has been notified of this incident and the findings.A project has been opened by the manufacturing facility to correct this issue.Capa 1134665.H3 other text : see section h.10.
Event or Problem Description
It has been reported that one 18g x 1.88in (1.3 x 48 mm) angiocath has been found with a loose needle before use.The following has been provided by the initial reporter: on (b)(6) 2019, medical staff found that the angiocath's needle pulled out of hub during pre-use examination.

• Brand Name: 18G X 1.88IN (1.3 X 48 MM) ANGIOCATH
• 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: 9371850
• Report Number: 9610048-2019-00339
• Device Sequence Number: 3079975
• Product Code: FOZ
• UDI-Device Identifier: 30382903811473
• UDI-Public: 30382903811473
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• 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): 12/18/2019

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: Health Professional
• Device Expiration Date: 06/30/2023
• Device Catalogue Number: 381147
• Device Lot Number: 8180804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/21/2019
• Initial Date Received by Manufacturer: 11/06/2019
• Supplement Date Received by Manufacturer: 11/06/2019
• Initial Report FDA Received Date: 11/25/2019
• Supplement Report FDA Received Date: 12/18/2019
• 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