• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BECTON DICKINSON, S.A. BD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BECTON DICKINSON, S.A. BD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE Back to Search Results
Catalog Number 301229
Device Problem Difficult to Advance (2920)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 05/01/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(6). A device evaluation is anticipated, but has not yet begun. Upon completion of the investigation and/or device history review, a supplemental report will be filed.
 
Event Description
It was reported that a bd plastipak¿ 30ml luer-lock syringe has difficult plunger movement, during use. There was no report of exposure, injury or medical intervention.
 
Manufacturer Narrative
Investigation summary: two unused samples were received for evaluation by our quality engineer. Upon visual inspection of the two samples, no damages or molding defects could be observed that would contribute to the alleged defect. A device history record review of lot 1612258p did not reveal any anomalies during the production of the provided lot number that could have contributed to difficult plunger movement. During the manufacturing process break out force, sustaining force, and silicone content tests are performed to ensure that all products are within specification. Break out force, sustaining force, and silicone content tests were performed on ten retained sampled of the same lot number as reported. All test results were within specification. As no issues were identified during the manufacturing process that could have contributed to the reported defect, a definite cause for this incident could not be determined. We can confirm that the root cause of the non-conformance is not related to a manufacturing defect. Based on severity and occurrence no formal capa is required according to internal procedure.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameBD PLASTIPAK¿ 30ML LUER-LOCK SYRINGE
Type of DeviceSYRINGE
Manufacturer (Section D)
BECTON DICKINSON, S.A.
camino de valdeolivia
s/n
san agustin de guadalix
MDR Report Key7599106
MDR Text Key111447613
Report Number3003152976-2018-00239
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 distributor,foreign,other
Type of Report Initial,Followup
Report Date 06/26/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/13/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date11/30/2021
Device Catalogue Number301229
Device Lot Number1612258P
Was Device Available for Evaluation? No Answer Provided
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received05/28/2018
Is This a Reprocessed and Reused Single-Use Device? No

Patient Treatment Data
Date Received: 06/13/2018 Patient Sequence Number: 1
-
-