MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. FIBEROPTIX ULTRA 8 IAB: 8FR 30CC; INTRA- AORTIC BALLOON FIBER OPTIC

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.

• Brand Name: FIBEROPTIX ULTRA 8 IAB: 8FR 30CC
• Type of Device: INTRA- 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 Key: 6193192
• MDR Text Key: 62965210
• Report Number: 1219856-2016-00287
• Device Sequence Number: 1
• Product Code: DSP
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K021462
• Number of Events Reported: 1
• 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

1 Patient was Involved in the Event

• Date FDA Received: 12/21/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 08/31/2017
• Device Catalogue Number: IAB-05830-LWS
• Device Lot Number: 18S16F0043
• Other Device ID Number: 00801902034724
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 12/06/2016
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/11/2017
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 06/24/2016
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1