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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER 18G, 10CM FULL TRAY INTRAVASCULAR CATHETER

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BARD ACCESS SYSTEMS POWERGLIDE MIDLINE CATHETER 18G, 10CM FULL TRAY INTRAVASCULAR CATHETER Back to Search Results
Catalog Number M118101
Device Problems Break (1069); Detachment Of Device Component (1104)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 04/13/2017
Event Type  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 reay1529 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by the facility that during placement the catheter sheared off during insertion, 5 cm of the catheter was retained in the patient's arm.
 
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 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 that the catheter was sheared off during insertion was confirmed and was determined to be related to use of the device. The proximal segment of one 18g powerglide catheter, which consisted of the purple hub and green strain relief sleeve, was returned for investigation. The catheter segment extended 4. 6cm from the distal end of the green sleeve. The distal segment of the catheter was not returned for investigation. A microscopic examination revealed that the catheter was scored within the lumen near the distal tip, which is typical of damage caused by a needle. A crescent shaped slit was observed at the distal end of the catheter segment. The adjoining surfaces of the crescent shaped slit were noted to be glossy and striated. The cross section at the distal tip of the catheter was dull and slightly granular. The break in the catheter appeared to be a result of complications with the insertion process. The damage to the catheter appeared to have been initiated with the sharp edge of the needle tip. 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. ¿ no further action is required because the complainant event could not be related to a deficiency in product manufacture or deficiency while under correct product use.
 
Event Description
It was reported by the facility that during placement the catheter sheared off during insertion, 5 cm of the catheter was retained in the patient's arm.
 
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Brand NamePOWERGLIDE MIDLINE CATHETER 18G, 10CM FULL TRAY
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
teresa johnson
605 n. 5600 w.
salt lake city, UT 84116
8015225435
MDR Report Key6544355
MDR Text Key74421779
Report Number3006260740-2017-00566
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K133856
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 05/11/2017
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/04/2017
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date11/30/2017
Device Catalogue NumberM118101
Device Lot NumberREAY1529
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/21/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/05/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 05/04/2017 Patient Sequence Number: 1
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