MAUDE Adverse Event Report: ADD-ON BURETTE SS VLV PS BALL VLV; INTRAVASCULAR ADMINISTRATION SET

Model Number	82115E
Medical Device Problem Codes	Disconnection (1171); Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/04/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that the add-on burette ss vlv ps ball vlv disconnected from the drip chamber below the tubing connection during use.The following information was provided by the initial reporter: "the connection between the ball valve drip chamber and became disconnected from the tubing below the chamber".
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 2021-05-18.The following are possible lot numbers: d4: medical device lot #: 20106171.D4: medical device expiration date: 2023-10-29.H4: device manufacture date: 2020-10-30.D4: medical device lot #: 20106172.D4: medical device expiration date: 2023-10-29.H4: device manufacture date: 2020-10-30.D4: medical device lot #: 20106173.D4: medical device expiration date: 2023-10-30.H4: device manufacture date: 2020-10-31.D4: medical device lot #: 20106174.D4: medical device expiration date: 2023-10-30.H4: device manufacture date: 2020-10-31.D4: medical device lot #: 20106175.D4: medical device expiration date: 2023-10-30.H4: device manufacture date: 2020-10-31.H6: investigation summary one 82115e product was received without packaging for investigation; however a review of the laser id from the smartsite component confirmed a possible lot number to be either 20106171, 20106172, 20106173, 20106174 or 20106175.Residual fluid was present in the product.A visual inspection confirmed the customer's experience as the set was received in two; the tubing was received separated from below the float valve of the burette.A closer inspection identified residual solvent around the end of the tubing.The details of this feedback were forwarded to the manufacturing site for investigation.Following a review of the manufacturing process, their analysis confirmed that the separation is most likely to have been caused by an insufficient amount of solvent having been applied to the tubing during the assembly process.This is a manually performed assembly step and is likely to have occurred due to human error.A review of the production records for lots 20106171, 20106172, 20106173, 20106174 and 20106175 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.In order to reduce the likelihood of operator error, the production personnel have been informed of this feedback to ensure that they are following the correct assembly process.A review of the customer feedback database indicates that this is an isolated occurrence with no further reports of this nature against the 82115e product over the past 12 months.
Event or Problem Description
It was reported that the add-on burette ss vlv ps ball vlv disconnected from the drip chamber below the tubing connection during use.The following information was provided by the initial reporter: "the connection between the ball valve drip chamber and became disconnected from the tubing below the chamber".

• Brand Name: ADD-ON BURETTE SS VLV PS BALL VLV
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12132527
• Report Number: 9616066-2021-51471
• Device Sequence Number: 14350668
• Product Code: FPA
• UDI-Device Identifier: 37613203009585
• UDI-Public: 37613203009585
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: K780130
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: foreign,other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/31/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Model Number: 82115E
• Device Catalogue Number: 82115E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 06/08/2021
• Supplement Date Received by Manufacturer: 08/31/2021
• Initial Report FDA Received Date: 07/07/2021
• Supplement Report FDA Received Date: 09/10/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1