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

MAUDE Adverse Event Report: BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 50ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON 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
 

BD MEDICAL (BD WEST) MEDICAL SURGICAL SYRINGE 50ML LL TIP 1ML 2 OZ IN 1/4 OZ PISTON SYRINGE Back to Search Results
Model Number 309653
Device Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problem Bacterial Infection (1735)
Event Date 07/06/2021
Event Type  Injury  
Manufacturer Narrative
Date of event: unknown. The date received by manufacturer has been used. There were multiple lot numbers reported to be involved. The information for each lot number is as follows: medical device lot #: 1112943, medical device expiration date: 03/31/2026, device manufacture date: 04/22/2021. Medical device lot #: unknown, medical device expiration date: unknown, device manufacture date: unknown. Investigation summary: it was reported by the health professional that two infections had occurred since january. To aid in the investigation, one sample and one photo were provided for evaluation by our quality team. The sample came in an unoriginal opened packaging blister. A visual inspection was performed and there is a white foreign matter at the bottom of the stopper. The sample was sent to the laboratory for analysis. The testing results did not provide a high enough percentage to draw a conclusion about the source of the foreign matter. The highest matches were plastic resin base and silicone. The photo shows a packaging blister top web and does not provide any information about the symptom reported by the customer. A device history record review was completed for provided material number and lot number. The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect. To date, there have been no other similar events reported for this lot. Based on the investigation and with the returned sample analysis the symptom reported by the customer could not be confirmed. Complaints received for this device and reported condition will continue to be tracked and trended. Our quality team regularly reviews the collected data for identification of emerging trends.
 
Event Description
It was reported two syringe 50ml ll tip 1ml 2 oz in 1/4 oz may be involved in infections. The following information was provided by the initial reporter: "we have had 2 central line infections in the nicu since january, which is highly unusual. Wondering if our sterile syringes aren't sterile. ".
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameSYRINGE 50ML LL TIP 1ML 2 OZ IN 1/4 OZ
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer (Section G)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
Manufacturer Contact
katie swenson
9450 south state street
sandy, UT 84070
8015296192
MDR Report Key12291762
MDR Text Key265582026
Report Number1911916-2021-00796
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K980987
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 08/03/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/06/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Model Number309653
Device Catalogue Number309653
Device Lot NumberSEE H.10.
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/23/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2021
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 08/06/2021 Patient Sequence Number: 1
-
-