MAUDE Adverse Event Report: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN.; INTRAVASCULAR CATHETER

Catalog Number 38182314

Device Problem Device Operates Differently Than Expected (2913)

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

Event Date 09/18/2017

Event Type  malfunction  

Manufacturer Narrative

(b)(6).A sample is not available for evaluation.However, a no sample investigation and device history record review will be completed.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the safety mechanism of the bd insyte¿ autoguard¿ shielded iv catheter 22 g x 1 in.Failed to function properly.There was no report of exposure, injury or medical interventions.

Manufacturer Narrative

Investigation: samples or photos have not received for analysis of the incident in question.Dhr/ qn/ ncmr review: assembled lot: 7179974, used in the claimed final product lot: 7195922 of insyte autoguard 22g x 1.00 was analyzed for "needle retraction" and ¿part activation¿ tests, and it was not evidenced failure in the activation of the part during the performing of these tests.However, "catheter over bevel" records have been evidenced that may cause the defect lie distance out of the specification which indirectly may lead to "needle activation failure".Qn/ ncmr review: it was evidenced quality notification (qn) # (b)(4) for the lie distance defect, which involves the assembly lot: 7179974.Although this nonconformity treats the lie distance defect, according to the investigations of this quality notification, the defect may lead to a needle retraction failure as reported in this complaint.After analysis of the qn/ ncmr of the claimed product, it was possible to confirm the complaint of the needle retraction failure.Based on a severity assessment and occurrence it was determined that no capa is required at this time.The complaint was added to the complaint database for trend analysis, which is regularly monitored.Although it has been evidenced the record of the quality notification above mentioned, during the investigations of this complaint it has been verified that the defect of this non-conformity could indirectly lead to the incident in question.However, it was not possible to determinate precisely its root cause to date.For more details check quality notification #: (b)(4).

• Brand Name: BD INSYTE¿ AUTOGUARD¿ SHIELDED IV CATHETER 22 G X 1 IN.
• 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 ; 9450 south state street; sandy, UT 84070 ; 8015652845
• MDR Report Key: 6969319
• MDR Text Key: 90772750
• Report Number: 9610048-2017-00044
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 00382903818235
• UDI-Public: 00382903818235
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: K952861
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/29/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/23/2017
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 06/30/2020
• Device Catalogue Number: 38182314
• Device Lot Number: 7195922
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 09/28/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 07/28/2017
• 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