MAUDE Adverse Event Report: GRA SET V/NV QS MC 60D 3SS; INTRAVASCULAR ADMINISTRATION SET

Model Number	10012564
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Unknown manufacturer: there are multiple bd locations where this unspecified bd device may have been manufactured.A catalog and lot number could not be confirmed for this incident and without this information we are unable to determine where the device was manufactured.Therefore, bd corporate headquarters in (b)(4) has been listed and the (b)(4) fda registration number has been used for the manufacture report number.Device expiration date: unknown.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: medical device lot #: 20115237, medical device expiration date: 2023-11-02, device manufacture date: 2020-10-29.Medical device lot #: unknown medical device expiration date: unknown, device manufacture date: unknown.Medical device lot #: 20106218 medical device expiration date: 2023-10-23, device manufacture date: 2020-10-10.The customer's address is unknown: (b)(6)  has been used as a default.  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 3 gra set v/nv qs mc 60d 3ss experienced component separation, and leakage.The following information was provided by the initial reporter: problem we are having is the bottom of the burette is not attached firmly, so that when an iv fluid is fed into the burette the bottom falls off and the fluid spills all over the floor.Normally the burette is attached to a plastic seal that connects to a ball valve chamber that has a firm seal, but we have had 2 complaints in a week of the this issue happening.
Additional Manufacturer Narrative
H6: investigation summary: the customer provided a photo with clear evidence of separation of the burette and the portion above drip chamber.This verified the customer's complaint of separation.Without a physical sample provided for investigation, there is no way to determine the root cause of this failure.A device history record review for model 10012564 lot number 20106218 was performed.The search showed that a total of 6,003 units in 1 lot number was built on 23oct2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.H3 other text : see h10.
Event or Problem Description
It was reported that 3 gra set v/nv qs mc 60d 3ss experienced component separation, and leakage.The following information was provided by the initial reporter: problem we are having is the bottom of the burette is not attached firmly, so that when an iv fluid is fed into the burette the bottom falls off and the fluid spills all over the floor.Normally the burette is attached to a plastic seal that connects to a ball valve chamber that has a firm seal, but we have had 2 complaints in a week of the this issue happening.

• Brand Name: GRA SET V/NV QS MC 60D 3SS
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12389718
• Report Number: 2243072-2021-02195
• Device Sequence Number: 20014688
• Product Code: FPA
• UDI-Device Identifier: 50885403233744
• UDI-Public: 50885403233744
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K951922
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 09/17/2021

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: 10012564
• Device Catalogue Number: 10012564
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 08/02/2021
• Supplement Date Received by Manufacturer: 09/17/2021
• Initial Report FDA Received Date: 08/31/2021
• Supplement Report FDA Received Date: 10/07/2021
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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