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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS FULL KIT 18G X 10 CM WITH BIOPATCH AND PROBE COVER CATHETER,INTRAVASCULAR,THERAPEUTIC,SHORT-TERM LESS THAN 30 DAYS

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BARD ACCESS SYSTEMS FULL KIT 18G X 10 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 Fluid Leak (1250); Hole In Material (1293)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 01/22/2018
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 rebx0135 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that a 10cm powerglidestarted leaking and was found to have a pinhole in the "white part" of the catheter closest to the purple hub. It was removed from the patient, no harm to the patient was reported.
 
Manufacturer Narrative
The 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 damaged catheter was confirmed, but the exact cause was undetermined. One 18g x 10cm powerglide catheter was returned for investigation. The catheter was received in two segments. The proximal segment of the catheter extended less than 1mm from the green oversleeve. The distal catheter segment was nearly 10cm in length. The purple hub was attached to an extension set. A green and white colored residue was observed on the purple hub. The adjoining surfaces of the catheter were microscopically examined. A microscopic examination revealed that the cross section of the catheter was slightly uneven but perpendicular to the axis of the tubing. The surface of the cross section was glossy. It was reported that the powerglide was leaking and a pinhole was found in the white catheter near the purple hub. Besides the break near the hub, the external surface of the catheter revealed no pinholes in the catheter. It could not be determined if the break was a continuation of the hole. Based on the event description and condition of the returned sample, it appeared that the damage occurred during use, but the exact cause of the leak and possible subsequent break could not be determined. The product ifu includes warnings to prevent catheter damage during insertion. A lot history review (lhr) of rebx0135 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that a 10cm powerglide started leaking and was found to have a pinhole in the "white part" of the catheter closest to the purple hub. It was removed from the patient, no harm to the patient was reported.
 
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Brand NameFULL KIT 18G X 10 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 Key7319323
MDR Text Key101856350
Report Number3006260740-2018-00386
Device Sequence Number1
Product Code FOZ
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 company representative,user f
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/18/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/06/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberF318108PT
Device Lot NumberREBX0135
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/05/2018
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Home
Date Manufacturer Received03/16/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured10/01/2017
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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