Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 BD BLUNT FILL NEEDLE WITH FILTER; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
  • 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 BD BLUNT FILL NEEDLE WITH FILTER; MANUAL SURGICAL INSTRUMENT FOR GENERAL USE Back to Search Results
Model Number 305211
Device Problem Packaging Problem (3007)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 06/24/2021
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 22 bd blunt fill needles with filters experienced damaged packaging where sterility was compromised.The following information was provided by the initial reporter: during the 100% visual inspection at the customer's side, 22 packages were found to be damaged.
 
Manufacturer Narrative
H6: investigation summary it was reported that during the customer's visual inspection, 22 packages were found to be damaged.To aid in the investigation, three photos showing packaging blister top webs were provided for evaluation by our quality team.Two of the three photos show damage to the packaging blister top web.A device history record review was completed for provided material number 305211, lot number 0202380.The review did not reveal any detected quality issues during the production of this lot that could have contributed to the reported defect.The packaging process was verified finding everything acceptable.To date, there have been no other similar events reported for this lot.Based on the investigation and with the photo sample analysis the symptom reported by the customer is confirmed, but a probable root cause could not be offered.During inspection, no conditions were observed that could induce the symptom reported by the customer.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.H3 other text : see h10.
 
Event Description
It was reported that 22 bd blunt fill needles with filters experienced damaged packaging where sterility was compromised.The following information was provided by the initial reporter: during the 100% visual inspection at the customer's side, 22 packages were found to be damaged.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD BLUNT FILL NEEDLE WITH FILTER
Type of Device
MANUAL SURGICAL INSTRUMENT FOR GENERAL USE
Manufacturer (Section D)
BD MEDICAL (BD WEST) MEDICAL SURGICAL
1852 10th avenue
columbus NE 68601
MDR Report Key12305100
MDR Text Key266025849
Report Number1911916-2021-00805
Device Sequence Number1
Product Code GAA
UDI-Device Identifier30382903052111
UDI-Public30382903052111
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type foreign,other,user facility
Type of Report Initial,Followup
Report Date 08/17/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Model Number305211
Device Catalogue Number305211
Device Lot Number0202380
Was Device Available for Evaluation? No
Date Manufacturer Received08/17/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-