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Catalog Number 6018100
Device Problems Break (1069); Sticking (1597); Physical Resistance (2578)
Patient Problems Complaint, Ill-Defined (2331); Device Embedded In Tissue or Plaque (3165)
Event Date 01/20/2016
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 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 a break in the powerglide catheter was confirmed and the damage appears to be use related. One 18ga powerglide catheter was returned for investigation. The powerglide catheter was incomplete. The catheter tubing, which was curved at the distal end of the pink strain relief sleeve, extended 3. 0cm from the distal end of the pink sleeve. The catheter was still attached to the catheter handle, which was still attached to the safety mechanism. The safety mechanism had been engaged and was locked over the needle. Blood residue was visible within the catheter. The guidewire had been advanced and locked into place, but the guidewire push-off tab was missing from the returned device. A microscopic examination of the distal end of the returned catheter segment exhibited an irregular edge. There were areas of the catheter edge that are consistent with sharp instrument damage and areas of the edge that are consistent with a tear in the catheter material. A v-shaped puncture was also visible in the tubing near the location of the tear, which is consistent with a needle tip puncture. The catheter handle was removed from the safety mechanism and the catheter was removed from the catheter handle, which exposed the distal end of the guidewire within the needle. A microscopic examination of the guidewire revealed that the wire was intact and complete. After inserting the needle into the vein and advancing the guidewire until it fully extended and locked into place, the ifu instructs to ¿grip the plastic housing by holding the back grips and fully advance the catheter using the catheter handle. ¿ the ifu caustions, ¿always keep the housing stationary while advancing catheter handle. Do not hold the catheter handle stationary and retract the housing. ¿ 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 damage found on the returned sample is consistent with damage caused by re-inserting the needle back into the catheter or pulling the catheter back over the needle during the placement process. 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. A lot history review (lhr) of rezh0650 showed no other similar product complaint(s) from this lot number.
Event Description
The customer reported that they inserted a powerglide in the right basilica vein. The procedure went as normal but when they went to remove the needle, it felt like it was stuck in the catheter and met resistance. This resistance feeling disappeared but they reported removing the whole product and discovered that the catheter was broken. The doctor advised to take everything out. Once the catheter was removed, they discovered that a part of the catheter was still left in the patient under the skin and not in the vessel. They stated that it seemed like it had been curled like "c". The segment was about 6-7 cm. The patient is very sick and has sever down syndrome. After consulting their doctor, they decided to leave the catheter part inside the patient because they did not want the give anesthesia because of his diseases.
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Manufacturer (Section D)
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
Manufacturer Contact
maren treft
605 n. 5600 w.
salt lake city, UT 84116
MDR Report Key5555599
MDR Text Key42309145
Report Number3006260740-2016-00153
Device Sequence Number1
Product Code FOZ
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial
Report Date 03/16/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received04/07/2016
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Device Expiration Date07/31/2017
Device Catalogue Number6018100
Device Lot NumberREZH0650
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/30/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/30/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2015
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial