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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 Twisted/Bent (2981); Material Split, Cut or Torn (4008); Physical Resistance/Sticking (4012)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/19/2018
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate. Results are expected soon. A lot history review (lhr) of recv1660 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that during use of the catheter the nurse felt resistance and instinctively pulled back on it after it was deployed which caused the catheter to shear, the guidewire became bent. Patient experienced trauma but no major harm mentioned. On 12/4/18 - additional information received stated, "there was no cut down, snare, surgical removal necessary to remove the device. The clinician felt resistance as she was advancing the catheter after guidewire was successfully deploy. Her instinct was to remove the entire device but in doing so sheared the catheter. It was during removal that the tip of the guidewire was held up on the patient¿s tissue. ".
 
Event Description
It was reported that during use of the catheter the nurse felt resistance and instinctively pulled back on it after it was deployed which caused the catheter to shear, the guidewire became bent. Patient experienced trauma but no major harm mentioned. On 12/4/18 additional information received stated, "there was no cut down, snare, surgical removal necessary to remove the device. The clinician felt resistance as she was advancing the catheter after guidewire was successfully deploy. Her instinct was to remove the entire device but in doing so sheared the catheter. It was during removal that the tip of the guidewire was held up on the patient¿s tissue. ".
 
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 sheared catheter is confirmed and appears to be related to the use of the device. One 20 ga powerglide pro device was returned for investigation. Use residue was observed. The catheter was observed to be sheared 2. 2 cm from the distal end. The needle was observed to be protruding from the split in the catheter. The guidewire was observed to be intact at the location of the split in the catheter. A product label sticker was returned with ref: (b)(4) and lot: recv1660. Based on the position of the catheter and split location relative to the needle, it is likely that the catheter was sheared due to retraction against the needle bevel. The product ifu warns, ¿warning: 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. ¿ a lot history review (lhr) of recv1660 showed no other similar product complaint(s) from this lot number.
 
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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
MDR Report Key8164549
MDR Text Key130469126
Report Number3006260740-2018-03593
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
PMA/PMN Number
K162377
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 12/20/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received12/14/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Expiration Date11/30/2019
Device Model NumberN/A
Device Catalogue NumberF320088PT
Device Lot NumberRECV1660
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/11/2018
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received12/17/2018
Is This a Reprocessed and Reused Single-Use Device? No

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