• 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. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC INTRA- AORTIC BALLOON FIBER OPTIC

  • 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. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC INTRA- AORTIC BALLOON FIBER OPTIC Back to Search Results
Catalog Number IAB-05830-LWS
Device Problem Device Markings/Labelling Problem (2911)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/16/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4).
 
Event Description
It has been reported that during inspection it was found that the label affixed to the outside of the kit was ref: intra-aortic balloon (iab-05830-lws), 8fr. (2, 7 mm) - 30cc. However, the round label with the size indication '40cc' is on the box of the '30cc' intra-aortic balloon (iab). No patient involvement.
 
Manufacturer Narrative
(b)(4). Evaluation: the device was returned to teleflex for analysis. Our investigation confirmed the reported complaint. During our visual inspection, the outer box had 2 large, correct labels affixed to either size of the box. However, the outer box lid also included 2 small round "40cc" stickers (instead of "30cc") on the sides and on top of the box lid. The correct catheter was identified inside the box. The iab and insertion kit within the packaging was completely sealed and unused. The insertion kit label matches the reported complaint. No damage or abnormalities were noted to the kit. A device history record (dhr) review was conducted for the lot number/serial number with no relevant findings. The device passed all manufacturing specifications prior to release. There was no patient involvement reported. Teleflex assessed the risk for this reported issue and determined that there are no new or revised risks. Teleflex will continue to monitor for similar reports.
 
Event Description
It has been reported that during inspection it was found that the label affixed to the outside of the kit was ref: intra-aortic balloon (iab-05830-lws), 8fr. (2, 7 mm) - 30cc. However, the round label with the size indication '40cc' is on the box of the '30cc' intra-aortic balloon (iab). No patient involvement.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NameFIBEROPTIX ULTRA 8 IAB: 8FR 30CC
Type of DeviceINTRA- AORTIC BALLOON FIBER OPTIC
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
Manufacturer (Section G)
ARROW INTERNATIONAL INC.
9 plymouth street
everett MA 02149
Manufacturer Contact
anne rosenberger
2400 bernville road
reading, PA 19605
6104783117
MDR Report Key6193192
MDR Text Key62965210
Report Number1219856-2016-00287
Device Sequence Number1
Product Code DSP
Combination Product (y/n)N
Reporter Country CodeIT
PMA/PMN Number
K021462
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/21/2010
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/21/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date08/31/2017
Device Catalogue NumberIAB-05830-LWS
Device Lot Number18S16F0043
Other Device ID Number00801902034724
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/06/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/24/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-