Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 4F; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Model Number N/A
Device Problem Device Operates Differently Than Expected (2913)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 11/21/2017
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 rebt1203 showed no other similar product complaint(s) from this lot number.
 
Event Description
During picc placement, when pushing the catheter into the vein and flushing with saline the yellow line with the intravasal ecg disappears, when taking the catheter out from the patient the intravasal yellow line is present but again when placing the line in the patients vein all of the yellow goes away.The placer and her assistant checked the fen and the connection from the catheter without finding anything wrong with them.When changing to a new catheter it worked as it is supposed to.No patient injury reported.
 
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 that the 3cg wire was not tracing after insertion cannot be verified outside the clinical setting and with the condition of the items returned for investigation.One 4f s/l powerpicc solo with 3cg stylet was returned for investigation.Evidence of use was observed on the returned sample.The catheter had been trimmed to length at the 35cm depth mark.The 3cg stylet wire had been retracted through the t-lock extension set.The white wire had been unbundled.The twist clip was still attached to the wire.The gray fin with red and black lead wires was not returned for investigation.A microscopic examination revealed the presence of conductive epoxy at the distal end of the stylet, which confirms that the stylet was complete.A continuity and resistance test revealed that the product was within specification.Complications associated with the clinical setting that cannot be replicated in the lab may have affected the functional performance of the device.It is unknown if there was poor continuity with the electrodes and their connections.The gray fin with red and black lead wires was not returned for investigation.At this time, based on the evidence provided with the returned samples, it is unknown what caused the alleged problems.A lot history review (lhr) of rebt1203 showed no other similar product complaint(s) from this lot number.
 
Event Description
During picc placement, when pushing the catheter into the vein and flushing with saline the yellow line with the intravasal ecg disappears, when taking the catheter out from the patient the intravasal yellow line is present but again when placing the line in the patients vein all of the yellow goes away.The placer and her assistant checked the fen and the connection from the catheter without finding anything wrong with them.When changing to a new catheter it worked as it is supposed to.No patient injury reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 4F
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
Manufacturer (Section G)
BARD REYNOSA S.A. DE C.V. -9617592
blvd. montebello #1
parque industrial colonial
reynosa, tamaulipas
MX  
Manufacturer Contact
shelly gilbert
605 n. 5600 w.
salt lake city, UT 84116
8015225640
MDR Report Key7123777
MDR Text Key95485144
Report Number3006260740-2017-02250
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741138973
UDI-Public(01)00801741138973
Combination Product (y/n)N
Reporter Country CodeSW
PMA/PMN Number
K091324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/02/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number2194108
Device Lot NumberREBT1203
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/15/2017
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/17/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured06/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
-
-