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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC 4F NURSE BASIC TRAY WITH MICROINTRODUCER (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS POWERPICC 4F NURSE BASIC TRAY WITH MICROINTRODUCER (SINGLE-LUMEN); CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problems Break (1069); Therapy Delivered to Incorrect Body Area (1508)
Patient Problems Infiltration into Tissue (1931); No Known Impact Or Consequence To Patient (2692)
Event Date 02/21/2019
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of reby2379 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the patient used the catheter for more than 4 months.During the maintenance, when the catheter was used for injection, liquid flow was found at the puncture point.Contrast agent was injected with the gastrointestinal machine, and the contrast agent was found exuded under the armpit and the subclavian vein.After the whole catheter was pulled out, it was found damaged at 12.5 cm scale.
 
Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, 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 leak is confirmed and appears to be related to the use of the device.One 4 fr powerpicc catheter was returned for investigation.Evidence of use was present on the device.A horizontal split was observed between the 12 and 13 cm depth markers.One photo sample of a powerpicc sl catheter was also provided and appears to depict the same device returned.Microscopic observation of the split revealed matte discoloration near the edges.The corners of the split propagated longitudinally.The location of the catheter appeared to be compressed.The characteristics of the damage observed is suggestive that the damage was caused by material fatigue of the catheter.The wall thickness was measured at the 15 cm depth marker and was found to be within specification.Repeated kinking of the device likely led to the formation of a split in the catheter; therefore, the complaint is confirmed.The product ifu states, "avoid placement or securement of the catheter where kinking may occur, to minimize stress on the catheter, patency problems or patient discomfort." a lot history review (lhr) of reby2379 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the patient used the catheter for more than 4 months.During the maintenance, when the catheter was used for injection, liquid flow was found at the puncture point.Contrast agent was injected with the gastrointestinal machine, and the contrast agent was found exuded under the armpit and the subclavian vein.After the whole catheter was pulled out, it was found damaged at 12.5 cm scale.
 
Event Description
It was reported that the patient used the catheter for more than 4 months.During the maintenance, when the catheter was used for injection, liquid flow was found at the puncture point.Contrast agent was injected with the gastrointestinal machine, and the contrast agent was found exuded under the armpit and the subclavian vein.After the whole catheter was pulled out, it was found damaged at 12.5 cm scale.
 
Manufacturer Narrative
H11:section a through f - the information provided by bd 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 bd.The following were reviewed as part of this investigation: patient severity, complaint and lot history review, 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 leak is confirmed but the exact cause could not be determined from the photo sample provided.One photo sample of a powerpicc sl catheter.The catheter being held and a circumferential split is is present.The material appears to be lighter in color which is indicative of the material being stretched or kinked in that location.The surface characteristics cannon be clearly observed through the photo sample provided.Based on the condition of the device shown, possible contributing factors include material fatigue due to kinking or over pressurization.Since a split in the catheter is present, the complaint is confirmed but the exact cause remains unknown.A lot history review (lhr) of reby2379 showed no other similar product complaint(s) from this lot number.
 
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Brand Name
POWERPICC 4F NURSE BASIC TRAY WITH MICROINTRODUCER (SINGLE-LUMEN)
Type of Device
CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
MDR Report Key8420380
MDR Text Key138948563
Report Number3006260740-2019-00568
Device Sequence Number0
Product Code LJS
PMA/PMN Number
K070996
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup,Followup
Report Date 08/16/2019
2 Devices were Involved in the Event: 1   2  
2 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number3174118
Device Lot NumberREBY2379
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/24/2019
Event Location Hospital
Date Manufacturer Received07/23/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number0
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