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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; STAND, INFUSION

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C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS CRESCENT SLIDING POST; STAND, INFUSION Back to Search Results
Catalog Number PIC0220
Device Problems Misconnection (1399); Material Twisted/Bent (2981)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/06/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of juey1044 showed five other similar product complaint(s) from this lot number.
 
Event Description
It was reported the statlock securement clip does not close properly.No other information was provided.
 
Event Description
It was reported the statlock securement clip does not close properly.No other information was provided.
 
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 evaluation, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of difficulty closing the statlock tab was confirmed.The product returned for evaluation was a statlock picc plus catheter securement device.The investigation findings are consistent with damage caused by pushing the securement tab at an angle while attempting to close the device.This issue can be avoided by centering the thumb about the middle of the tab and pressing directly downwards.The returned product sample was evaluated and the following observations were made which were consistent with this failure type: an attempt to test the functionality of the lock was unsuccessful and the top left latch was observed to be completely broken from the catch base.The left catch contained plastic deformation which was consistent with forceful closure of the latch into the top of the catch face.The left tab hinge exhibited an off-axis crease and contained damage outside the hinge crease.This failure type was recreated in the laboratory using non-complainant samples by closing the tab at an angle, or by pressing outside the center of the tab, and the features observed on the laboratory samples were similar to those on the returned complainant sample.The nature of the observed damage, and the point of contact on the catch base as well as the characteristics of the hinge damage, are evidence that the damage was caused by misalignment of the doors when closing the device.Pushing the tab at an angle can cause the latch to miss the catch base and can permanently bend the latch.An examination of the sample revealed no potential damage/defect related to manufacture of the product.
 
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Brand Name
STATLOCK PICC PLUS CRESCENT SLIDING POST
Type of Device
STAND, INFUSION
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11814171
MDR Text Key250345592
Report Number3006260740-2021-01818
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 other,user facility
Type of Report Initial,Followup
Report Date 06/08/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPIC0220
Device Lot NumberJUEY1044
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/18/2021
Initial Date Manufacturer Received 04/21/2021
Initial Date FDA Received05/12/2021
Supplement Dates Manufacturer Received06/08/2021
Supplement Dates FDA Received07/02/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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