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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS CRESCENT SLIDING POST BULK KIT; STAND, INFUSION
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C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS CRESCENT SLIDING POST BULK KIT; STAND, INFUSION Back to Search Results
Model Number N/A
Device Problem Malposition of Device (2616)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 12/29/2020
Event Type  malfunction  
Manufacturer Narrative
The manufacturer has received the sample and will evaluate.Results are expected soon.A lot history review (lhr) of judwf114 showed no other similar product complaint(s) from this lot number.
 
Event Description
It was reported by tm "facility reported an issue with a biostable picc w/pasv.It was reported that the picc is normally fixated with the statlock; however, for the past few months, this facility has been needing to replace picc¿s because the first picc¿s placed have come out due to the bad fixation of the statlock device, at the skin.It was also noted that the case comes off from the adhesive plaster, very easily.The customer stated they noticed a change in statlock from a foam pad material to a ¿canvas¿ cloth tape material.The canvas cloth tape material has had issues of not sticking to skin resulting in picc malposition." no other information was provided.This report addresses lot #judwf114.
 
Event Description
It was reported by tm "facility reported an issue with a biostable picc w/pasv.It was reported that the picc is normally fixated with the statlock; however, for the past few months, this facility has been needing to replace picc¿s because the first picc¿s placed have come out due to the bad fixation of the statlock device, at the skin.It was also noted that the case comes off from the adhesive plaster, very easily.The customer stated they noticed a change in statlock from a foam pad material to a ¿canvas¿ cloth tape material.The canvas cloth tape material has had issues of not sticking to skin resulting in picc malposition." no other information was provided.This report addresses lot #judwf114.
 
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 batch history, applicable previous investigation(s), labeling, applicable manufacturing records, sample analysis and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of unable to secure statlock is confirmed but the exact cause remains unknown.One photo sample of two statlock securement devices were provided for evaluation.One statlock device shown on the left has the liner backing present.The statlock shown on the right side is shown without its adhesive backing.The locking doors are open on both devices.The retainer on the right side statlock appears to be shifted to the right which suggests loss of adhesion may have occurred.Based on the photo sample provided, possible contributing factors includes excessive handling of the device and chemical degradation of the adhesive.Since the exact cause could not be determined from the image provided, the complaint is confirmed, cause unknown.A review of the manufacturing records did not reveal any evidence to suggest a manufacturing related root cause contributed to the reported event.H3 other text : evaluation findings are in section h.11.
 
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Brand Name
STATLOCK PICC PLUS CRESCENT SLIDING POST BULK KIT
Type of Device
STAND, INFUSION
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11215979
MDR Text Key229468726
Report Number3006260740-2020-21416
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type distributor,other
Type of Report Initial,Followup
Report Date 01/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberN/A
Device Catalogue NumberPICNS001
Device Lot NumberJUDWF114
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/30/2020
Date Manufacturer Received01/29/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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