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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: C.R. BARD, INC. (BASD) -3006260740 STATLOCK SLIDING POST CRESCENT PAD SKIN PREP; STAND, INFUSION
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C.R. BARD, INC. (BASD) -3006260740 STATLOCK SLIDING POST CRESCENT PAD SKIN PREP; STAND, INFUSION Back to Search Results
Catalog Number PIC0220CE
Device Problem Detachment of Device or Device Component (2907)
Patient Problems No Consequences Or Impact To Patient (2199); No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/14/2021
Event Type  malfunction  
Manufacturer Narrative
The device has not been returned to the manufacturer for evaluation.A lot history review (lhr) of juep2260 showed no other similar product complaint(s) from this lot number.Device not returned for evaluation.
 
Event Description
It was reported the plastic clamps on the statlock device falls off the band aid so the picc catheter is at risk for sliding out off the patient because it is not fixed.So plastic clamps are not fixed correct on the band aid.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 lot history review, applicable previous investigation(s), sample (if available), applicable manufacture records, and applicable fmea documents.Based on a review of this information, the following was concluded: the complaint of a detached retainer is confirmed and was determined to be manufacturing related.Two picc plus statlock kits were returned for evaluation.An initial visual observation showed one of the kits was returned open and one kit was returned sealed.The retainer of the statlock device returned in the open kit was found to be completely detached from the pad, and the underside of this detached retainer was observed to be tacky.A microscopic observation revealed good adhesive coverage on the underside of both retainers; however, strings of adhesive were found on the underside of the retainer of the sealed sample when an attempt was made to remove it from the pad.This suggests that the adhesive between the retainer and pad may not have been fully cured.The investigation has been forwarded to the manufacturing facility for further evaluation, and bd is working closely with the manufacturing facility to prevent recurrence of the reported event.A lot history review (lhr) of juep2260 showed one other similar product complaint(s) from this lot number.The complaints for this lot number (juep2260) have been reported from multiple facilities in denmark.H3 other text : evaluation findings are in section h.11.
 
Event Description
It was reported the plastic clamps on the statlock device falls off the band aid so the picc catheter is at risk for sliding out off the patient because it is not fixed.So plastic clamps are not fixed correct on the band aid.No other information was provided.04/21/2021- two devices were returned.This report addresses the first device.
 
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Brand Name
STATLOCK SLIDING POST CRESCENT PAD SKIN PREP
Type of Device
STAND, INFUSION
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
MDR Report Key11274432
MDR Text Key231210269
Report Number3006260740-2021-00192
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 company representative,health
Type of Report Initial,Followup
Report Date 04/21/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/03/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberPIC0220CE
Device Lot NumberJUEP2260
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer02/10/2021
Date Manufacturer Received04/21/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Other;
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