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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 INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS DOT PG PRO 20G 8CM FULL INTRAVASCULAR CATHETER Back to Search Results
Model Number F120081
Device Problem Hole In Material (1293)
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 hole in the catheter was confirmed and was determined to be related to use of the device. One 20g x 8cm powerglide catheter, which consisted of the purple hub and pink strain relief sleeve, was returned for investigation. The deployment system was not returned for investigation. A functional test revealed a hole in the catheter 6mm from the distal end of the pink sleeve. A microscopic examination revealed that the catheter was scored longitudinally with a circumferential slit at the distal end of the longitudinal score line. Sharp edges were observed along the slit with striations on adjoining surfaces of the breach in the tubing. These characteristics at the leak site are consistent with a needle puncture. 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. This may result in damage to the catheter. 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. ¿ the ifu also states, ¿do not perforate, tear, or fracture the catheter with the needle or guidewire during the procedure. ¿ a lot history review (lhr) of rebs1202 showed no other similar product complaint(s) from this lot number.
 
Event Description
Per sales rep, the facility reported a pin hole was found in the power pro midline catheter. The catheter was removed. No reported patient injury.
 
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 rebs1202 showed no other similar product complaint(s) from this lot number.
 
Event Description
Per sales rep, the facility reported a pin hole was found in the power pro midline catheter. The catheter was removed. No reported patient injury.
 
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Brand NameDOT PG PRO 20G 8CM 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
shauna nielson
605 n. 5600 w.
salt lake city, UT 84116
8015225536
MDR Report Key6961510
MDR Text Key194227561
Report Number3006260740-2017-01855
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/09/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received10/19/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberF120081
Device Catalogue NumberF120081
Device Lot NumberREBS1202
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/17/2017
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received11/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured05/01/2017
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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