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U.S. Department of Health and Human Services

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

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BECTON DICKINSON IND. CIRURGICAS LTDA BD PLASTIPAK¿ SYRINGE Back to Search Results
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.
 
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Brand NameBD PLASTIPAK¿ SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON IND. CIRURGICAS LTDA
550 rua cyro correia pereira
curitiba
MDR Report Key7720488
MDR Text Key115360195
Report Number3003916417-2018-00164
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
PMA/PMN Number
N/A
Number of Events Reported1
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 Received07/25/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number990173
Device Lot Number7362890
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/03/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 07/25/2018 Patient Sequence Number: 1
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