Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

MAUDE Adverse Event Report: PUREWICK CORPORATION ¿ 3012224959 PUREWICK COLLECTION CANISTER - 1200CC
  • 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
 

PUREWICK CORPORATION ¿ 3012224959 PUREWICK COLLECTION CANISTER - 1200CC Back to Search Results
Catalog Number 1200CCJ
Device Problems Break (1069); Labelling, Instructions for Use or Training Problem (1318)
Patient Problems No Consequences Or Impact To Patient (2199); No Known Impact Or Consequence To Patient (2692)
Event Type  malfunction  
Manufacturer Narrative
The investigation is still in progress.Once the investigation is complete, a supplemental report will be filed.The device was not returned.
 
Event Description
It was reported that urine was being drawn directly into the drydoc pump because the instructions were not clear on how to connect the collection canister to the drydoc machine.As a result, there was alleged damage to the canister lid from the urine.No medical intervention was reported.
 
Manufacturer Narrative
The reported event was unconfirmed per review of the product's instructions for use; page 7 of the ifu, illustrates and provides instructions of how to set up the drydoc with the canister.The lot number is unknown therefore the device history record could not be reviewed.The instructions for use were found adequate and state the following: ¿inspect the shipping box for damage.If damage is noticed, contact liberator medical at (b)(6) immediately.Carefully remove the unit and all contents, including the packing material, from the shipping container and inspect carefully prior to use.¿ place the drydoc¿ vacuum station (a) next to the bed or chair where it will be used.It must be close enough for the 70¿ patient tubing (b) to easily reach the user.* avoid creating a tripping hazard with the patient tubing or drydoc¿ vacuum station.*the drydoc¿ vacuum station should be placed on a stable and even surface at or below the user¿s level.¿ plug the drydoc¿ vacuum station power cord into an electrical outlet.¿ place the collection canister (c) in the drydoc¿ vacuum station base and press down firmly on the lid.Attach the 16¿ vacuum tubing (d) to the drydoc¿ vacuum station connector port (e) and the connector port labeled ¿vacuum¿ (f) on the collection canister lid.¿ attach the 70¿ patient tubing (b) to the connector port labeled ¿patient¿ (g) on the collection canister lid.Connect the other end of the 70¿ patient tubing securely to purewick¿ fec (h).Caution: it is important that the port connections be connected correctly for proper operation of the drydoc¿ vacuum station.¿ turn on the drydoc¿ vacuum station by pressing the on/off switch on top of the drydoc¿ vacuum station.The drydoc¿ vacuum station is functioning when the switch illuminates and the pump makes a soft humming sound.The system is now ready for use.".
 
Event Description
It was reported that urine was being drawn directly into the drydoc pump because the instructions were not clear on how to connect the collection canister to the drydoc machine.As a result, there was alleged damage to the canister lid from the urine.No medical intervention was reported.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
PUREWICK COLLECTION CANISTER - 1200CC
Type of Device
COLLECTION CANISTER
Manufacturer (Section D)
PUREWICK CORPORATION ¿ 3012224959
203 gillespie way
el cajon CA 92020
MDR Report Key8228942
MDR Text Key132532423
Report Number1018233-2019-00165
Device Sequence Number1
Product Code NZU
UDI-Device Identifier00801741151798
UDI-Public(01)00801741151798
Combination Product (y/n)N
PMA/PMN Number
EXEMPT
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type consumer,distributor,other
Type of Report Initial,Followup
Report Date 03/22/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received01/08/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Lay User/Patient
Device Catalogue Number1200CCJ
Was Device Available for Evaluation? No
Date Manufacturer Received03/12/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
-
-