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

Catalog Number 388339

Device Problem Material Integrity Problem (2978)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/13/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).The customer, it was evidenced that the needle has glues on the cannula, the analysis of the corrective maintenance history showed "bad application of glue" during the manufacture of lot 7149712, which is enough to confirm this complaint.Samples/ photos: it was received one open and unused sample of asepto 25g product, catalog: 388339, lot: 7173777 for analysis.According to visual analysis of the sample it can be verified that the sample has drops of glue on the needle body.Dhr review: the following assembled wing (code: 004642bjf) lots used in the claimed final product lot 7173777 were analyzed: 7087505 assembled on machines 5004 and 5005 in the period from 06 to 17 april, 2017; 7149712 assembled on machines 5004 and 5005 in the period from 02 to 06 june, 2017; the batches in question were analyzed as test of "cannula dirty of glue" and no records of this defect were detected for the batches analyzed.Qn/ ncmr review: there are no quality notification (qn) or non-conformity report records that could lead to this issue for the lots involved in this complaint.Based on the investigations, it was verified that the root cause for this incident was caused by a failure in the application of the needle glue in the wing, causing drops of this glue to reach the needle body generating the incident described in this complaint.

Event Description

It was reported before use of the scalp bd¿ asepto catheter the material contains slots, roughness, curling.The needle color is different.There was no report of injury or medical intervention.

• Brand Name: SCALP BD¿ ASEPTO CATHETER
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer (Section G): BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora
• Manufacturer Contact: brett wilko ; ave. pres.juscelino kubitschek; 273 francisco bernardino; juiz de fora ; 323229-517
• MDR Report Key: 7101244
• MDR Text Key: 94965402
• Report Number: 9610048-2017-00092
• Device Sequence Number: 1
• Product Code: FOZ
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,o
• Reporter Occupation: Health Professional
• Type of Report: Initial
• Report Date: 12/07/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/08/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2022
• Device Catalogue Number: 388339
• Device Lot Number: 7173777
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/09/2017
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/13/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/10/2017
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other