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: BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA. BD¿ WINGED 27G NEEDLE; BLOOD COLLECTION SET
  • 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 INDUSTRIAS CIRURGICAS, LTDA. BD¿ WINGED 27G NEEDLE; BLOOD COLLECTION SET Back to Search Results
Catalog Number 388340
Device Problems Break (1069); Entrapment of Device (1212)
Patient Problem Foreign Body In Patient (2687)
Event Date 07/31/2018
Event Type  Injury  
Manufacturer Narrative
(b)(6).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 during use of the bd¿ winged 27g needle disconnected from the plastic device (butterfly), the needle was in the back of the patient's hand.An x-ray was performed.Removal of the needle was not possible due to acute edema.The patient was advised to return within 15 days for re-evaluation.The patient was prescribed an oral anti-inflammatory.There was no additional information reported at this time.
 
Event Description
It was reported that during use of the bd¿ winged 27g needle disconnected from the plastic device (butterfly), the needle was in the back of the patient's hand.An x-ray was performed.Removal of the needle was not possible due to acute edema.The patient was advised to return within 15 days for re-evaluation.The patient was prescribed an oral anti-inflammatory.There was no additional information reported at this time.
 
Manufacturer Narrative
Correction: due to an it issue beginning on 7/3/2018, previously filed emdrs did not contain required fields.This supplemental emdr is filed to provide the following omitted fields: sex: male.Event attributed to: other.Device single use?: no.Device returned to manufacture: yes.Investigation summary: samples and photos were returned for evaluation.Bd can verify the sample was received with a broken needle.Ms.(b)(6) informed that the piece of needle is still in the patient's hand and she asked us to contact ms.(b)(6) for more information.(b)(6) reported that at the time of withdrawing the needle, it separated from the device, remaining inside the patient's hand.Patient was redirected to the prompt service where the x-ray of the region was performed, being possible to visualize the metallic part.The needle was not withdrawn from the patient because the region was with edema, patient was advised to return within 15 days for evaluation.Patient was not hospitalized, but is performing daily monitoring by the institution due to the occurrence.Due to the region presenting edema, it was prescribed the anti-inflammatory nimesulide 100mg oral.Dhr review: the following assembled wing (code: 004643bjf) lots used in the claimed final product lot 8134691 were analyzed: 7360779 assembled on machines 5004 and 5005 in the period from 18-jan-2018 to 22-jan-2018; 8087977 assembled on machines 5004 and 5005 in the period from 23-apr-2018 to 26-apr-2018; the batches in question were analyzed for the "challenge pull off traction test ", "damaged component " tests and no records of these defects were found or anything that could clearly indicate the cause of the defect claimed in the batch history.Qn/ ncmr review: there are no quality notification (qn) or nonconformity report of "needle pulled out of hub" and anything that clearly could lead to this complaint for the claimed lots and sub assembled lot.Unplanned maintenance: the corrective maintenance history in the manufacturing period of the assembly lot involved in this complaint was evaluated and it was not verified records related to "needle pulled out of hub".A root cause could not be determined.Complaints received for this device and the reported defect will continue to be tracked and trended.The information will be captured in the trend reports and monitored monthly.Collected data are regularly reviewed to identify emerging trends.Based on this, a capa is not needed at this time.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
BD¿ WINGED 27G NEEDLE
Type of Device
BLOOD COLLECTION SET
Manufacturer (Section D)
BECTON DICKINSON INDUSTRIAS CIRURGICAS, LTDA.
ave. pres.juscelino kubitschek
273 francisco bernardino
juiz de fora
MDR Report Key7805087
MDR Text Key117869475
Report Number9610048-2018-00117
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
N/A
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 08/27/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Other
Device Expiration Date04/30/2023
Device Catalogue Number388340
Device Lot Number8134691
Date Manufacturer Received08/02/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age46 YR
-
-