MAUDE Adverse Event Report: GREINER BIO-ONE GMBH NO INFORMATION; NEEDLE, HYPODERMIC, SINGLE LUMEN

Model Number NO INFORMATION

Device Problem Leak/Splash (1354)

Patient Problem Blood Loss (2597)

Event Type  Injury  

Manufacturer Narrative

Complaint number: (b)(4).No samples (actual or unused) were received from customer.Please advise the customer that we must have samples returned for quality assurance so that a proper investigation may be conducted.Should the customer encounter any issues in the future, please advise them to save the samples for investigative purposes.No pictures were provided.No material # was provided.No further details were provided.We forwarded the complaint to our supplier for their investigation and comments.Based upon the provided batch # they have reviewed materials/batches 450040/17f01b and 450042/17f01b.Manufacturing and inspection records of the concerned materials/batches were reviewed and no abnormalities which could be related to the reported event were observed.Retain samples of the concerned materials/batches were visually inspected.No rubber sleeves were off the needle hubs and no abnormalities such as damage or molding defects were observed on the rubber sleeves or hubs.The fitting strength between the rubber sleeve and hub was measured.All results were within range of standards.No rubber sleeves came off easily.The complaint cannot be determined.The entire production process for this product (including rubber sleeves being put onto the needle hubs) is performed by automatic assembly machines.In the manufacturing process, molded parts are inspected per log and only parts which pass are utilized.No process applies any damage to the hub or rubber sleeve during manufacturing.Every needle is inspected by automatic inspection machines on the assembly line to prevent flowing of defective product.If the product should have defects, it is detected and discarded automatically.The assembly machines have multiple sensors and cameras to ensure there is no abnormality during assembly.There is 100% inspection of these assemblies.Appearance, dimension and function are checked at regular intervals during in process inspection and release inspection.Any samples used for inspections are discarded.

Event Description

Customer states that during venipuncture rubber sheath came off as the tubes were being changed out.Blood leaked onto the tubes, the holder, and phlebotomist's gloves.Customer could not confirm after which tube in series (1st, 2nd, etc.) the sheath came off nor if blood exposure occurred.

• Brand Name: NO INFORMATION
• Type of Device: NEEDLE, HYPODERMIC, SINGLE LUMEN
• Manufacturer (Section D): GREINER BIO-ONE GMBH; bad haller strasse 32; kremsmuenster, 4550 ; AU 4550
• 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: 9739670
• MDR Text Key: 190510411
• Report Number: 8020040-2018-00003
• Device Sequence Number: 1
• Product Code: FMI
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: UNKNOWN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 02/21/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: NO INFORMATION
• Device Catalogue Number: NO INFORMATION
• Device Lot Number: 17F01B
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 03/15/2018
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention