MAUDE Adverse Event Report: ADMIN SET 20DP W/ FILTER Y SITE CLMP; INTRAVASCULAR ADMINISTRATION SET

Model Number	B2-70071-DF
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/28/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
Event or Problem Description
It was reported that admin set 20dp w/ filter y site clmp had foreign matter.The following information was provided by the initial reporter: material no: b2-70071-df.Batch no: 21015465.It was reported the set had loose pieces of the spike on the side once it was spiked into the bag.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-06-28.H6: investigation summary: a notification of loose material in spike was received, however, samples were requested to confirm the reported failure mode.2 samples of the b2-70071-df were received at (b)(6) on june 28th, 2021.The samples were visually inspected and no issues in the spike were observed, however, a quick revision with the customer was performed on (b)(6) 2021, and according with the customer words the loose material was observed in the iv bag when the set is connected.The samples were tested connecting the syringe to an iv bag, during the testing, no loose material or particles in the iv bag and in the drip chamber were observed in both samples.Dhr review.Model: b2-70071-df.Lot number: 21015465.Lot qty: (b)(4).Qn/deviation: zero.Mfg date: jan/06/2021.*no qn¿s were found during the manufacturing of the lots reported in this complaint.
Event or Problem Description
It was reported that admin set 20dp w/ filter y site clmp had foreign matter.The following information was provided by the initial reporter: material no: b2-70071-df, batch no: 21015465.It was reported the set had loose pieces of the spike on the side once it was spiked into the bag.

• Brand Name: ADMIN SET 20DP W/ FILTER Y SITE CLMP
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 11891443
• Report Number: 9616066-2021-51159
• Device Sequence Number: 3710066
• Product Code: FPA
• UDI-Device Identifier: 00814371020167
• UDI-Public: 00814371020167
• Combination Product (Y/N): N
• Initial Reporter State: MA
• Initial Reporter Country: US
• PMA/510(K) Number: NA
• 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): 07/16/2021

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: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: B2-70071-DF
• Device Catalogue Number: B2-70071-DF
• Device Lot Number: 21015465
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/28/2021
• Initial Date Received by Manufacturer: 04/28/2021
• Supplement Date Received by Manufacturer: 07/16/2021
• Initial Report FDA Received Date: 05/26/2021
• Supplement Report FDA Received Date: 08/04/2021
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/06/2021
• 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