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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS 4 FR PICC BASIC TRAY W/M; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS
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BARD ACCESS SYSTEMS 4 FR PICC BASIC TRAY W/M; CATHETER, INTRAVASCULAR, THERAPEUTIC, LONG-TERM GREATER THAN 30 DAYS Back to Search Results
Catalog Number 7755405
Device Problem Migration or Expulsion of Device (1395)
Patient Problem Device Embedded In Tissue or Plaque (3165)
Event Date 10/29/2015
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 device has not been returned to the manufacturer, at this time, for evaluation.A lot history review (lhr) review is not possible, as no manufacturing lot number has been provided by the complainant.
 
Event Description
It was reported by nurse that on a patient caring a tube who returned home made a phone call and reported that the inserted picc allegedly slipped into the vascular inside the body.Later the patient was sent to department of interventional surgery of the hospital to have it removed.
 
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 broken catheter was confirmed and the cause appears to be use related.The product returned for evaluation was one 4fr single-lumen groshong catheter.Usage residues were observed throughout the sample.A complete break was observed in the catheter between the 31cm and 33cm depth markings.The segment of catheter containing the 32cm depth marking was not returned for evaluation.Tactile evaluation of the sample revealed severe tensile weakness with shape memory at the break sites.Microscopic examination of the break sites revealed dull and granular surfaces with uneven sharply defined break edges whose shape resembled a hill and valley.The orifice of the break sites was irregularly elliptical.It appears the catheter underwent a tensile event which resulted in breaks in the catheter.Care should be taken when securing, accessing, and maintaining catheters to avoid causing tensile damage.
 
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Brand Name
4 FR PICC BASIC TRAY W/M
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.
blvd montebello #1
parque industrial colonial
reynosa tamaulipas 88780
MX   88780
Manufacturer Contact
maren treft
605 n. 5600 w.
salt lake city, UT 84116
8015225964
MDR Report Key5243261
MDR Text Key31925394
Report Number3006260740-2015-00547
Device Sequence Number1
Product Code DQY
Combination Product (y/n)N
Reporter Country CodeCH
PMA/PMN Number
K871080
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation Other
Type of Report Initial,Followup
Report Date 11/04/2015
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number7755405
Device Lot NumberUNOBTAINABLE
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/08/2015
Is the Reporter a Health Professional? No
Event Location Hospital
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/23/2015
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received02/01/2016
Was Device Evaluated by Manufacturer? Yes
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Hospitalization;
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