• 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 RELION® INSULIN SYRINGE 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
 

BECTON DICKINSON RELION® INSULIN SYRINGE PISTON SYRINGE Back to Search Results
Catalog Number 309657
Device Problems Material Fragmentation (1261); Device Contamination with Chemical or Other Material (2944)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/22/2019
Event Type  malfunction  
Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured. A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured. (b)(4). Date of event: unknown. The date received by manufacturer has been used for this field. Medical device expiration date: unknown. Pma / 510(k)#: k151766 ((b)(6)); k980987 ((b)(6)). Device manufacture date: unknown. Investigation summary: since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident. No root cause can be determined as no samples were received. The lot number is unknown, therefore device history record review (dhr) or quality notification review (qn) could not be performed. 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. Rationale: capa is not required at this time.
 
Event Description
It was reported that there were 3 occurrences where mold was on the paper backing of a relion® insulin syringe. The following information was provided by the initial reporter: it was reported the paper backing flakes off when it is wiped with ipa and mold arises. Per verbatim: rep calling on behalf of a customer who would prefer to not be identified that uses syringes for individualized cancer medicine. They use syringes 309657 (3), 309646 (5) ( (#) is how many affected). Syringes are received sterile then they wipe them down with ipa which is causing the paper backing to flake off and get in the product which results in mold. They want to know if there is an alternative product without paper backing, may try kitting the syringes before shipping. No product to return, no dates ongoing issue, no lot numbers provided.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameRELION® INSULIN SYRINGE
Type of DevicePISTON SYRINGE
Manufacturer (Section D)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer (Section G)
BECTON DICKINSON
1 becton drive
franklin lakes NJ 07417
Manufacturer Contact
brett wilko
9450 south state street
sandy, UT 84070
8015652341
MDR Report Key8591507
MDR Text Key148429595
Report Number2243072-2019-00879
Device Sequence Number1
Product Code FMF
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
SEE H.10
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other,user facili
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 04/24/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/08/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number309657
Device Lot NumberUNKNOWN
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/22/2019
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 05/08/2019 Patient Sequence Number: 1
-
-