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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 10CM FULL INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS DOT PG PRO 20G 10CM FULL INTRAVASCULAR CATHETER Back to Search Results
Model Number N/A
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, frequency analysis, applicable previous investigation(s), sample (if available), applicable fmea documents, labeling, and applicable manufacture records. Based on a review of this information, the following was concluded: the complaint of a punctured catheter is confirmed and was determined to be use related. One 20 g powerglide pro was returned for evaluation. An initial visual observation showed blood residue throughout the returned sample. The guidewire was observed to be stuck in the catheter which was observed to be punctured by the needle and bent backward. A microscopic observation revealed the weld tip of the guidewire was intact, and the rest of the guidewire was also observed to be undamaged. The bevel of the needle was observed to be slightly damaged. Evidence of bunching was observed near the tip of the catheter. The edges of the split were observed to be mostly straight and well-defined with some jagged edges near the proximal end of the split. Most of the split surface was observed to be plastically deformed and had a granular surface texture; however, striations were observed on some sections near the proximal end of the split, indicating the catheter was punctured by the needle and was subsequently torn. The damage found on the returned sample is consistent with damage caused by re-inserting the needle back into the catheter or pulling the catheter back over the needle during the placement process. The product ifu warns: ¿once the catheter has been advanced, do not re-insert the needle back into the catheter or pull the catheter back onto the needle. If the catheter needs to be repositioned, either do so without the aid of the needle, or remove both the catheter and the needle as a unit to prevent the needle from damaging or shearing the catheter. ¿.
 
Event Description
Per sales rep, the facility reported the nurse tried to thread wire and the catheter got caught up on the needle and sheared. No other information was provided. No patient harm was reported.
 
Manufacturer Narrative
The information provided by bard represents all of the known information at this time. Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bard. The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of rebq0956 showed no other similar product complaint(s) from this lot number.
 
Event Description
Per sales rep, the facility reported the nurse tried to thread wire and the catheter got caught up on the needle and sheared. No other information was provided. No patient harm was reported.
 
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Brand NameDOT PG PRO 20G 10CM FULL
Type of DeviceINTRAVASCULAR CATHETER
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX
Manufacturer Contact
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key6663771
MDR Text Key192863731
Report Number3006260740-2017-00904
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K153280
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type user facility
Reporter Occupation
Type of Report Initial,Followup
Report Date 07/24/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received06/23/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date02/28/2018
Device Model NumberN/A
Device Catalogue NumberF220101
Device Lot NumberREBQ0956
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer06/14/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/11/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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