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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS DOT PG PRO 20G 8CM FULL CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS DOT PG PRO 20G 8CM FULL CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number F120081
Device Problem Material Twisted/Bent (2981)
Patient Problem Pain (1994)
Event Type  malfunction  
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 device has not been returned, at this time, to the manufacturer for evaluation. A lot history review (lhr) of recq1252 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that after placement, the midline had kinked internally and was causing pain. The device was subsequently removed. No patient harm reported.
 
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 catheter kink is inconclusive due to poor sample condition. One 20 ga x 8 cm pflex catheter was returned for investigation. Use residue was observed throughout the sample. No apparent kinks in the catheter were observed. Manipulation of the sample revealed it to preferentially kink at the proximal end of the catheter. Based on the description of the reported event and condition of the returned sample, possible contributing factors include placement and securement technique. The catheter did not display any permanent kinking upon return but may have experienced kinking under clinical use; therefore, the complaint is inconclusive due to poor sample condition. A lot history review (lhr) of recq1252 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that after placement, the midline had kinked internally and was causing pain. The device was subsequently removed. No patient harm reported.
 
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Brand NameDOT PG PRO 20G 8CM FULL
Type of DeviceCATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS
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
tesha udy
605 n. 5600 w.
salt lake city, UT 84116
8015225819
MDR Report Key7682007
MDR Text Key114011670
Report Number3006260740-2018-01704
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 08/03/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/12/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF120081
Device Catalogue NumberF120081
Device Lot NumberRECQ1252
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/17/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received07/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured03/01/2018
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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