• 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 10ML REG PR SALINE 10ML FILL; PREFILLED SALINE 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 10ML REG PR SALINE 10ML FILL; PREFILLED SALINE SYRINGE Back to Search Results
Catalog Number 30654678
Device Problems Leak/Splash (1354); Failure to Deliver (2338)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/06/2020
Event Type  malfunction  
Manufacturer Narrative
There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 0114381, medical device expiration date: 2023-04-30, device manufacture date: 2020-04-23, medical device lot #: 0021634, medical device expiration date: 2023-01-31, device manufacture date: 2020-01-21.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
 
Event Description
It was reported that 3 syringe 10ml reg pr saline 10ml fill experienced difficult plunger movement during use.The following information was provided by the initial reporter: i have received the following product complaint for item number 30654678: 9 sodium chloride flushes, not flushing several sodium chloride flushes not flushing properly.Syringe does not move forward when you push on it and therefore you are not able to flush.This was not an isolated incident, this report is just one example lot numbers found with defective flushes so far: lot #0114381 (x2 flushes).Lot #0021634.
 
Manufacturer Narrative
H.6.Investigation: a device history record review was completed by our quality engineer team for provided lot numbers 0114381 and 0021634.The review did not reveal any detected abnormalities during the production process that could have contributed to this defect and all quality tests were found to be within specification.As a sample was unavailable for return, a thorough sample investigation could not be completed.Based on the investigation results, an exact cause for this incident could not be identified.
 
Event Description
It was reported that 3 syringe 10ml reg pr saline 10ml fill experienced difficult plunger movement during use.The following information was provided by the initial reporter: i have received the following product complaint for item number (b)(4): 9 sodium chloride flushes - not flushing several sodium chloride flushes not flushing properly.Syringe does not move forward when you push on it and therefore you are not able to flush.This was not an isolated incident, this report is just one example lot numbers found with defective flushes so far: lot #0114381 (x2 flushes) lot #0021634.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SYRINGE 10ML REG PR SALINE 10ML FILL
Type of Device
PREFILLED SALINE SYRINGE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key10625570
MDR Text Key213232717
Report Number1911916-2020-00926
Device Sequence Number1
Product Code NGT
UDI-Device Identifier00382903065462
UDI-Public00382903065462
Combination Product (y/n)N
PMA/PMN Number
K161552
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Type of Report Initial,Followup
Report Date 10/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number30654678
Device Lot NumberSEE H10
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/11/2020
Initial Date FDA Received10/05/2020
Supplement Dates Manufacturer Received09/11/2020
Supplement Dates FDA Received10/05/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
-
-