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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS FULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Material Puncture/Hole (1504); Difficult to Remove (1528); Material Separation (1562); Physical Resistance (2578)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/03/2018
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 manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of reby1136 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during the insertion procedure the nurse was able to thread the guidewire with no resistance. It was stated she did meet resistance when she attempted to thread the catheter and so she decided to remove the entire device. Removal was difficult and after it was removed the nurse found that the guidewire had punctured the catheter and was ¿looped¿. The guidewire also separated from the housing. No patient injury was reported.
 
Manufacturer Narrative
The following were reviewed as part of this investigation: patient severity, trend 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 the guidewire/catheter damage was confirmed and the cause appeared to be use-related. The product returned for evaluation was one 18ga x 8cm powerglide pro midline catheter assembly. The sample was received with the safety mechanism engaged and the catheter detached. The distal segment of the guidewire was detached from the assembly and remained inlaid through the catheter. Microscopic inspection of the guidewire revealed the weld tip to be intact. Inspection of the break in the guidewire revealed a granular fracture surface. Inspection of the split in the catheter revealed a granular fracture surface. Deformation and discoloration were observed in the vicinity of the split. Inspection of the tip of the catheter exhibited deformation. The catheter split characteristics were consistent with tearing type damage which appeared to be caused by contact with the guidewire. It appeared that the guidewire became kinked within the catheter and that subsequent tensile (pulling) stress on the wire caused both the catheter perforation and the guidewire elongation and breakage. Such kinking can occur if the catheter is withdrawn back onto the wire following advancement and if the wire is reinserted into the catheter following removal. A lot history review (lhr) of reby1136 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during the insertion procedure the nurse was able to thread the guidewire with no resistance. It was stated she did meet resistance when she attempted to thread the catheter and so she decided to remove the entire device. Removal was difficult and after it was removed the nurse found that the guidewire had punctured the catheter and was ¿looped¿. The guidewire also separated from the housing. No patient injury was reported.
 
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Brand NameFULL KIT 20G X 8 CM WITH BIOPATCH AND PROBE COVER
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
kelsey erickson
605 n. 5600 w.
salt lake city, UT 84116
8015225937
MDR Report Key7466764
MDR Text Key106717849
Report Number3006260740-2018-00815
Device Sequence Number1
Product Code FOZ
UDI-Device Identifier00801741140679
UDI-Public(01)00801741140679
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K162377
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 05/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/26/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberF320088PT
Device Lot NumberREBY1136
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer04/25/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received05/02/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2017
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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