MAUDE Adverse Event Report: TERUMO CORPORATION/TERUMO BCT TERUFLEX DRY COLLECTION BAG; TERUMO BLOOD BAG WITHOUT ANTICOAGULANT

Catalog Number 1BBD606A

Device Problem Human-Device Interface Problem (2949)

Patient Problem Needle Stick/Puncture (2462)

Event Date 04/15/2015

Event Type  malfunction  

Event Description

The customer reported a needle stick injury that occurred when a nurse was recapping the needle using a one handed technique after a therapeutic phlebotomy on a patient with hemachromatosis.Per the customer, the nurse will undergo the hospital's blood exposure protocol.The nurse is reported in healthy condition.The patient's (nurse) age and weight are unavailable at this time.The disposable set is not available for return because it was discarded by the customer.

Manufacturer Narrative

Investigation is in process.A follow-up report will be provided.

Manufacturer Narrative

Investigation: the set was not returned for investigation.The manufacturing and testing records were reviewed with no issues noted.No anomalies were observed in the phlebotomy needle part of the product.Reserve samples for this lot were visually examined with no anomalies noted.No similar reports have been received regarding this lot number.Root cause: the root cause for this needlestick injury is undetermined.

Event Description

The customer declined to provide patient's (nurse) age and weight.

• Brand Name: TERUFLEX DRY COLLECTION BAG
• Type of Device: TERUMO BLOOD BAG WITHOUT ANTICOAGULANT
• Manufacturer (Section D): TERUMO CORPORATION/TERUMO BCT; fujinomiya
• Manufacturer Contact: glenda o'neill ; 10811 w. collins ave; lakewood, CO 80215 ; 3032314051
• MDR Report Key: 4760285
• MDR Text Key: 19602483
• Report Number: 1722028-2015-00177
• Device Sequence Number: 1
• Product Code: KSR
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK950039
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional
• Reporter Occupation: Health Professional
• Type of Report: Initial,Followup
• Report Date: 04/15/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/08/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/01/2015
• Device Catalogue Number: 1BBD606A
• Device Lot Number: 120718F3
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/19/2015
• 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