• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 1.5IN PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BARD ACCESS SYSTEMS POWERLOC SAFETY INFUSION SET 20G X 1.5IN PORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR Back to Search Results
Model Number N/A
Device Problem Activation Problem (4042)
Patient Problems Exposure to Body Fluids (1745); Needle Stick/Puncture (2462)
Event Type  malfunction  
Manufacturer Narrative
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 manufacturer has received the sample and is pending evaluation. Results are expected soon. A lot history review (lhr) of asdns0074 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (asdns0074) have been reported from facility. - attachment: [(b)(4)].
 
Event Description
It was reported via medwatch "powerloc used for access to port. The "lock out" legs did not engage on retraction leaving the needle exposed which caused a needle stick to provider. The stick came just as the needle was being placed in sharps container so the actual needle is not available. We immediately went to the same supply bin and tested another one from what we believe is the exact same lot and the defect was duplicated. We pulled that lot and have a sample from that lot available for analysis. " this report addresses the first of two devices.
 
Manufacturer Narrative
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, applicable previous investigation(s), sample analysis, applicable fmea documents, applicable manufacturing records, and labeling. Based on a review of this information, the following was concluded: the complaint that the safety mechanism did not engage was inconclusive due to the sample condition. It was reported that the safety mechanism on both an infusion set that was used to access a port and an unused same lot sample could not be activated. One 20g x 1. 5¿ powerloc infusion set was returned for investigation. The needle shaft was bent 0. 48¿ from the distal tip of the needle. No evidence of use was observed on the sample, which indicates that the returned product may have been the same lot sample. A microscopic examination revealed material deformation in the yellow base of the safety mechanism adjacent to the needle shaft. The bend in the needle may have affected the activation of the safety mechanism; however, a functional test revealed that the safety mechanism could be locked over the needle tip without resistance. Since the used sample was not returned for investigation and since the safety mechanism was activated over the bent needle of the returned sample, the complaint was inconclusive. A lot history review (lhr) of asdns0074 showed one other similar product complaint(s) from this lot number. The complaints for this lot number (asdns0074) have been reported from facility. - attachment: [(b)(4)].
 
Event Description
It was reported via medwatch "powerloc used for access to port. The "lock out" legs did not engage on retraction leaving the needle exposed which caused a needle stick to provider. The stick came just as the needle was being placed in sharps container so the actual needle is not available. We immediately went to the same supply bin and tested another one from what we believe is the exact same lot and the defect was duplicated. We pulled that lot and have a sample from that lot available for analysis. " this report addresses the first of two devices.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand NamePOWERLOC SAFETY INFUSION SET 20G X 1.5IN
Type of DevicePORT & CATHETER, IMPLANTED, SUBCUTANEOUS, INTRAVASCULAR
Manufacturer (Section D)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer (Section G)
BARD ACCESS SYSTEMS
605 n. 5600 w.
salt lake city UT 84116
Manufacturer Contact
kayla olsen
605 n. 5600 w.
salt lake city, UT 84116
8015225010
MDR Report Key9878943
MDR Text Key186723201
Report Number3006260740-2020-01013
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K060812
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 03/31/2020
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received03/25/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model NumberN/A
Device Catalogue Number0652015
Device Lot NumberASDNS0074
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location Hospital
Date Manufacturer Received03/26/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured01/01/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

-
-