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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: ARROW INTERNATIONAL INC. ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8"; CATHETER, INTRAVASCULAR, THER
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ARROW INTERNATIONAL INC. ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8"; CATHETER, INTRAVASCULAR, THER Back to Search Results
Catalog Number PR-05052-HP
Device Problems Leak/Splash (1354); Insufficient Information (3190)
Patient Problem Death (1802)
Event Date 05/06/2020
Event Type  Death  
Manufacturer Narrative
(b)(4).
 
Event Description
The customer reports: patient who on (b)(6) 2020 had picc inserted in msd and on (b)(6) 2020 began to leak due to the connection tie in (y) in the proximal lumen pathway.Other information: patient death is not associated with the use of the device - patient diagnosed with gastric adenocarcinoma.
 
Manufacturer Narrative
Qn# (b)(4).The actual device was not returned; however, the customer provided two videos for evaluation.Visual examination of the videos confirmed a leak in the juncture hub during use.However, full visual inspection could not be performed as no sample was returned for analysis.A device history record review was performed and no relevant findings were identified.The instructions-for-use provided with this kit warns the user, "do not apply excessive force in placing or removing catheter.Failure to do so can result in catheter breakage.If placement or withdrawal cannot be easily accomplished, an x-ray should be obtained and further consultation requested." the customer report of a catheter leak was confirmed by visual examination of the customer supplied videos.The videos showed the catheter leaking from an apparent hole in the juncture hub during use.A full complaint verification testing could not be performed as the sample was not returned for analysis.A device history record review was performed and no relevant findings were identified.Without the device to evaluate, the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.
 
Event Description
The customer reports: patient who on (b)(6) 2020 had picc inserted in msd and on (b)(6) 2020 began to leak due to the connection tie in (y) in the proximal lumen pathway.Other information: patient death is not associated with the use of the device - patient diagnosed with gastric adenocarcinoma.
 
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Brand Name
ARROW PICC SET 2-LUMEN: 5 FR X 19-5/8"
Type of Device
CATHETER, INTRAVASCULAR, THER
Manufacturer (Section D)
ARROW INTERNATIONAL INC.
reading PA
MDR Report Key10105528
MDR Text Key193062538
Report Number9680794-2020-00264
Device Sequence Number1
Product Code LJS
Combination Product (y/n)N
PMA/PMN Number
K042126
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,foreign,health pr
Type of Report Initial,Followup
Report Date 05/19/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received06/01/2020
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Expiration Date05/31/2021
Device Catalogue NumberPR-05052-HP
Device Lot Number14F19F0015
Was Device Available for Evaluation? No
Date Manufacturer Received07/08/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Death;
Patient Age63 YR
Patient Weight53
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