MAUDE Adverse Event Report: GREINER BIO-ONE NA INC VACUETTE TUBE 6 ML K2E K2EDTA 13X100 PINK CAP-PINK RING, NON-RIDGED; BLOOD SPECIMEN COLLECTION DEVICE

Model Number 456279

Device Problem Decrease in Suction (1146)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  malfunction  

Manufacturer Narrative

(b)(4).Received 2rks 456279/b200138c for evaluation.No pictures were received by the customer.We have no further complaints on the material/batch.We have no further inventory of the material/batch.Tubes were verified to be correctly assembled and had the correct fill guide line position.No visual deviation in fill volume, sporadic low or high fill, could be observed in the tested samples.All tubes tested filled within the +/-10% tolerance range.Additive content was found to be within specification in all tested samples.No deviations could be observed in the samples.Complaint could not be duplicated.

Event Description

Customer states tubes are losing vacuum.The tube failing is causing patients to have to be recollected.It is an inconvenience to their patients who need to come back in to have blood drawn multiple times for same test.For occurrences of tubes losing vacuum, customer advises that they were having more than 5 tubes a day.The laboratory staff is trained and signed off on how to collect tubes.They have been observed on applying proper pressure to the tubes during collection.If they reinsert the tube into the holder, more times than not they get blood return and are able to fill up the tubes properly.For blood collection, they are using bd straight 22g eclipse needles or vacuette safety blood collection sets with lauer adapter.If a safety blood collection set is used, a waste tube is drawn.This is occurring with phlebotomists as well as other departments as they start ivs for patients.Customer states racks of tubes were packaged with loose wrapping, causing tubes to come out of their rack position when still wrapped.Customer purchases by the case from cardinal.Customer assumes the racks of tubes are coming in the same wrapping/packaging that greiner ships them to cardinal in.Cardinal will pack the racks of tubes in boxes with other items when cardinal ships from their warehouse.The cases of tubes come in their original boxes from what the customer can see but unsure due to the racks are wrapped in several different types of wrapping/packaging.Some racks are wrapped with thin cellophane and wrapped tighter but it tears and the tubes get loose in the box.Other racks of tubes are in a thicker plastic wrapping that is loose, and the tubes get loose within the plastic wrapping/packaging.Customer provided pictures of how rack of tubes was received.Customer questions integrity of tubes due to the tubes coming out of position in rack and is having vacuum issues with these tubes.

• Brand Name: VACUETTE TUBE 6 ML K2E K2EDTA 13X100 PINK CAP-PINK RING, NON-RIDGED
• Type of Device: BLOOD SPECIMEN COLLECTION DEVICE
• Manufacturer (Section D): GREINER BIO-ONE NA INC; 4238 capital drive; monroe NC 28110
• Manufacturer (Section G): GREINER BIO-ONE NA INC; 4238 capital drive; monroe NC 28110
• Manufacturer Contact: manfred abel ; 4238 capital drive; monroe, NC 28110 ; 7042617800
• MDR Report Key: 10576982
• MDR Text Key: 219210491
• Report Number: 1125230-2020-00023
• Device Sequence Number: 1
• Product Code: JKA
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K971236
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 09/23/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/23/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 07/13/2021
• Device Model Number: 456279
• Device Catalogue Number: 456279
• Device Lot Number: B200138C
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/31/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1