MAUDE Adverse Event Report: TERUMO CORPORATION TERUFLEX; BB*D606A EMPTY BAG 600ML

Catalog Number 1BBD606A

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Pain (1994)

Event Date 09/17/2020

Event Type  Injury  

Manufacturer Narrative

Investigation: the set was not available for investigation and we therefore conducted the following investigations based on the information provided.In the phlebotomy needle assembly process, the phlebotomy needle is assembled through the processes of bonding the cannula and hub, drying glue, inspecting the bevel of the needle by an image detector, and putting the protector over the cannula.Concerning the inspection by the image detector, the detector detects a collapse or a bend a\ the tip of which the size is 50 m.Any needles with such a collapse or bend are eliminated as defect.We reviewed the manufacturing record and inspection record of the reported lot number and no anomalies were observed in these records.In addition, the image detector is checked once a week for its accuracy.We confirmed that no abnormalities were observed in the detector checking which had been performed before and after the production of the product in question.We therefore think that the detector worked properly at the time of production.Phlebotomy needles are assembled in the environment with cleanliness control (grade c).We reviewed the related record and confirmed that any abnormalities relating to manufacturing environment had not been observed during the production of the reported lot number.The product in question is tested for the appearance of the needle tip and shaft on a sample basis.We reviewed the testing and inspection record of the reported lot number and its adjacent lot numbers.All the test items revealed no abnormalities and satisfied the standards.We examined one set of the retained sample of the reported lot number for penetration resistance.We confirmed that the results satisfied the standards.Regarding the reported lot number, we investigated whether any complaints had been reported.We confirmed that complaints had not been reported by any other customers as of (b)(6) 2020.Root cause: we were not able to identify the cause of the issue since we did not see any abnormalities in the manufacturing record, testing and inspection record, or retained samples.In the product, we did not find any factors that could have been related to the occurrence of the event.

Event Description

The customer reported that a blood collection was done for research purposes.Anticoagulant citrate dextrose solution a (acd-a) was added to the whole blood bag to collect the blood.It was a 5 minute draw with no complaints from the donor.Donor's pain at the draw site started 1 week post donation, but the donor did not seek treatment until 3 weeks later.The donor was then treated by her doctor with antibiotics for a possible infection at the needle site.The customer called the donor back on (b)(6) 2020.The donor stated she still was feeling minor pain, so the customer recommended the donor reach out to her doctor for a follow up appointment.The customer has not spoken to the donor since (b)(6) 2020.The disposable set is not available because it was discarded by the customer.

• Brand Name: TERUFLEX
• Type of Device: BB*D606A EMPTY BAG 600ML
• Manufacturer (Section D): TERUMO CORPORATION; fujinomiya, ; JA
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11089256
• MDR Text Key: 226831856
• Report Number: 1722028-2020-00582
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): Y
• Report Source: Manufacturer
• Source Type: health professional
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 12/29/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 11/30/2022
• Device Catalogue Number: 1BBD606A
• Device Lot Number: 191216F3
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 12/04/2020
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Other; Required Intervention
• Patient Age: 51 YR
• Patient Weight: 59