MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE

Catalog Number 990173

Device Problems Leak/Splash (1354); Material Separation (1562)

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

Event Date 07/03/2018

Event Type  malfunction  

Manufacturer Narrative

A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that bd insyte¿ autoguard¿ bc shielded iv catheter had separation, leakage, and malfunction. There was no report of serious injury or medical intervention.

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: sex: female. Event attributed to: other. Device single use?: no. Device returned to manufacture: yes. A sample was returned for evaluation. After reviewing the batch history and maintenance data, we can confirm the plunger rod failure defect. According to the maintenance analysis, the defect is related to a pressure variation in the press. The correction was treated in maintenance order. A quality notification was opened to record the defect. The hesitation defect in the stopper region occurred due to a pressure variation in the hydraulic system injection pump of the press. In this way the machine did not have enough pressure to fill the mold and form the product. The problem has been corrected by performing intervention and adjustments to the hydraulic pump. A corrective action was implemented to solve the problem. Complaints received for this device and reported condition will continue to be tracked and trended. Information will be captured on trend reports and monitored monthly. Our business team regularly reviews the collected data for identification of emerging trends.

Event Description

It was reported that bd insyte autoguard bc shielded iv catheter had separation, leakage, and malfunction. There was no report of serious injury or medical intervention.

• Brand Name: BD PLASTIPAK¿ SYRINGE
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 7720488
• Report Number: 3003916417-2018-00164
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463000408
• UDI-Public: 7891463000408
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,other
• Type of Report: Initial,Followup
• Report Date: 08/28/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/25/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2022
• Device Catalogue Number: 990173
• Device Lot Number: 7362890
• Was Device Available for Evaluation?: No Answer Provided

Was the Report Sent to FDA?

• Event Location: No Information
• Date Manufacturer Received: 07/03/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Outcome(s): Other