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: ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT
  • 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
 

ARROW INTERNATIONAL INC. EPIDURAL CATHETERIZATION SET; ANESTHESIA CONDUCTION KIT Back to Search Results
Catalog Number MP-17019-TIP
Device Problem Bent (1059)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/23/2018
Event Type  malfunction  
Manufacturer Narrative
(b)(4).The device has not been returned for investigation at this time.Teleflex will continue to monitor and trend related events.
 
Event Description
Issue reported that the anesthesiologist tried to insert an epidural but the catheter could not pass through the needle so he removed the needle and realized that the tip of the needle was bent.The anesthesiologist used a new kit.After the insertion of the needle he did the same step and again the catheter could not pass through the needle.He removed the.
 
Event Description
Issue reported that the anesthesiologist tried to insert an epidural but the catheter could not pass through the needle so he removed the needle and realized that the tip of the needle was bent.The anesthesiologist used a new kit.After the insertion of the needle he did the same step and again the catheter could not pass through the needle.
 
Manufacturer Narrative
(b)(4).A device history record review was performed on the epidural needle with no relevant findings.Visual inspection could not be performed as no sample was returned by the customer for investigation.However, the customer did return a photo that clearly shows a bent tip on an epidural needle (reference files (b)(4)).Additional testing of the needle tips was performed by the manufacturing site to determine tip strength.Testing was performed to compare needle tips strengths from five available sets of different needles.The test concluded that the needle sets had very similar results.A review of design change history for part number nz-05500-001 was performed as a part of this investigation.No design changes have been made to this product in the past two years that would have led to this complaint.A review of the quality inspection report from the vendor of the cannula (nz-05500-001) found no material issues for lot # 72p17d0042 (vendor lot # mm170325aj).Other remarks: a corrective action is not required at this time.The damage was discovered during use.Therefore, based on the photo of the sample received and the time of discovery, operational context caused or contributed to this event.Complaint verification testing could not be performed as no sample was returned for analysis.However, the reported complaint of the needle tip being bent was confirmed based on a photo received from the customer.A device history record review was performed on the epidural needle with no evidence to indicate a manufacturing related issue.No material issues were found from the vendor for the cannula.Also, a needle tip strength study was performed by the manufacturing site which revealed very similar results with five different sets of needles.Therefore, based upon the information and photo provided, the observed needle damage, and the time of discovery, operational context caused or contributed to this event.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
EPIDURAL CATHETERIZATION SET
Type of Device
ANESTHESIA CONDUCTION KIT
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key7280372
MDR Text Key100530230
Report Number3003737899-2018-00012
Device Sequence Number1
Product Code CAZ
Combination Product (y/n)N
PMA/PMN Number
K103658
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 01/23/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/19/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date10/31/2019
Device Catalogue NumberMP-17019-TIP
Device Lot Number13F17L0209
Was Device Available for Evaluation? Yes
Date Manufacturer Received03/14/2018
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Age21 YR
Patient Weight91
-
-