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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY W; CATHETER,INTRAVASCULAR,THERAPEUTIC,LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY W; 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 01/11/2018
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) of rebv1669 showed no other similar product complaint(s) from this lot number.Device has not been returned for evaluation.
 
Event Description
It was reported that the picc was inserted on (b)(6) 2018, and that the insertion was uneventful; with the exception of being unable to properly remove the introducer by splitting it normally.It was stated the introducer did not split completely and the nurse had to use a hemostat to carefully remove the introducer from around the picc.The nurse was able to do this and finish the insertion of the picc.There was no patient injury.
 
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 damaged microintroducer was confirmed and the cause was determined to be manufacturing related.One 5fr x 7cm microintroducer was returned for investigation.The tabs had been split and the sheath had been peeled.One half of the sheath had separated from the tab and was not returned for investigation.The tab that separated from the sheath was received in two pieces.The tab fractured at the distal end of the handle.Hemostat marks were visible in the handle.It was reported that hemostats were used to remove the introducer from around the picc.The complaint sample was forwarded to the manufacturing facility for further review.Reynosa evaluation: the complaint ¿introducer snapped¿ is confirmed.On one of the parts of the sheath was present part of the molding.This part was an excess of resin produced during the molding process.The cause of this is manufacturing related.This will be tracked internally.A lot history review (lhr) of rebv1669 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the picc was inserted on (b)(6) 2018, and that the insertion was uneventful; with the exception of being unable to properly remove the introducer by splitting it normally.It was stated the introducer did not split completely and the nurse had to use a hemostat to carefully remove the introducer from around the picc.The nurse was able to do this and finish the insertion of the picc.There was no patient injury.
 
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Brand Name
POWERPICC SOLO CATHETER WITH SHERLOCK 3CG (TPS) STYLET 5F MAXIMAL BARRIER TRAY W
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 Key7234136
MDR Text Key98877343
Report Number3006260740-2018-00086
Device Sequence Number1
Product Code LJS
UDI-Device Identifier00801741034602
UDI-Public(01)00801741034602
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K091324
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,user f
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 06/08/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/01/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue Number1295108D
Device Lot NumberREBV1669
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/01/2018
Is the Reporter a Health Professional? Yes
Event Location Hospital
Date Manufacturer Received05/28/2018
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/01/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
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