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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 SLIDING POST CRESCENT PAD W/SKIN PREP STAND, INFUSION

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C.R. BARD, INC. (BASD) -3006260740 STATLOCK PICC PLUS SLIDING POST CRESCENT PAD W/SKIN PREP STAND, INFUSION Back to Search Results
Model Number N/A
Device Problem Detachment of Device or Device Component (2907)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/21/2021
Event Type  malfunction  
Manufacturer Narrative
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 appears to be manufacturing related. One picc plus statlock device with a foam pad and adjustable posts, the detached retainer of what appears to be a picc plus statlock device with a foam pad and adjustable posts, and one empty package were returned for evaluation. An initial visual observation showed a few pieces of foam on the bottom side of the underside of the detached retainer. No damage was observed on the intact statlock device. An attempt was made to separate the retainer of the intact statlock sample and while some small tears formed in the foam pad, the retainer was found to be firmly attached to the foam pad. A microscopic observation revealed poor adhesive coverage on the underside of the detached retainer, which likely occurred during the manufacturing process. The investigation was 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 juey1089 showed one other similar product complaint(s) from this lot number.
 
Event Description
It was reported that the plastic part of statlock allegedly found to be broken. There was no reported patient injury. No other information was provided. (b)(6) 2021: the returned sample was found to have a detached retainer.
 
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Brand NameSTATLOCK PICC PLUS SLIDING POST CRESCENT PAD W/SKIN PREP
Type of DeviceSTAND, INFUSION
Manufacturer (Section D)
C.R. BARD, INC. (BASD) -3006260740
605 north 5600 west
salt lake city 84116
Manufacturer (Section G)
DAVOL SURGICAL INNOVATIONS -9616067
ave. roberto fierro #6408
parque industrial aeropuerto
cd. juarez, chih s.a. de c.v. 32690
MX 32690
Manufacturer Contact
johanna de oliveira
605 north 5600 west
salt lake city 84116
8015950700
MDR Report Key12544331
MDR Text Key273740676
Report Number3006260740-2021-04037
Device Sequence Number1
Product Code FOX
Combination Product (y/n)N
Reporter Country CodeJA
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type other,user facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 09/18/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/28/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue NumberVPPCSPCE
Device Lot NumberJUEY1089
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer08/09/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/08/2021
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured11/01/2020
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 09/28/2021 Patient Sequence Number: 1
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