MAUDE Adverse Event Report: BI-EXT SET 15CM SMALL BORE SPIN NUT; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	385163
Medical Device Problem Code	Leak/Splash (1354)
Health Effect - Clinical Code	Chemical Exposure (2570)
Date of Event	06/08/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.
Event or Problem Description
It was reported that bi-ext set 15cm small bore spin nut leaked.The following information was provided by the initial reporter: leakage during administration of chemo (cisplatin), leakage at the level of qsyte.Mrs.Had liquid (chemo) on her garment, further worked according to procedure.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d10: device available for eval yes, d10: returned to manufacturer on: 2021-07-23 d4: medical device lot #: 0121421 d4: medical device expiration date: 2023-04-30 h4: device manufacture date: 2020-05-26 d4: medical device lot #: 0092897 d4: medical device expiration date: 2023-03-31 h4: device manufacture date: 2020-05-26 d4: medical device lot #: 0272324 d4: medical device expiration date: 2023-09-30 h4: device manufacture date: 2020-10-13 h6: investigation summary bd received two samples submitted for evaluation.The reported issue was not confirmed upon inspection and leakage testing of the samples.Since the reported failure was not confirmed a root cause cannot be established.A device history record review showed no non-conformances associated with this issue during the production of batches 0121421, 0272324.Batch 0092897 had a quality notification for ¿septum within housing¿, but neither of the samples show that defect.A review of our risk management documentation was performed and indicates that the potential risk of the reported event was assessed appropriately.We appreciate you taking the time to bring this observation to our attention.Complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.Our business team regularly reviews the collected data for identification of emerging trends.See h10.
Event or Problem Description
It was reported that bi-ext set 15cm small bore spin nut leaked.The following information was provided by the initial reporter: leakage during administration of chemo (cisplatin), leakage at the level of qsyte.Mrs.Had liquid (chemo) on her garment, further worked according to procedure.
Additional Manufacturer Narrative
The following field was updated due to additional information: b.3.Date of event: 6/8/2021.
Event or Problem Description
It was reported that bi-ext set 15cm small bore spin nut leaked.The following information was provided by the initial reporter: leakage during administration of chemo (cisplatin), leakage at the level of qsyte.Mrs.Had liquid (chemo) on her garment, further worked according to procedure.

• Brand Name: BI-EXT SET 15CM SMALL BORE SPIN NUT
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• MDR Report Key: 12147374
• Report Number: 9610847-2021-00317
• Device Sequence Number: 19876140
• Product Code: FPA
• UDI-Device Identifier: 00382903851638
• UDI-Public: 00382903851638
• Combination Product (Y/N): N
• Initial Reporter Country: BE
• PMA/510(K) Number: K142527
• 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,Followup
• Report Date (Section B): 10/13/2021

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 Catalogue Number: 385163
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2021
• Initial Date Received by Manufacturer: 06/10/2021
• Supplement Date Received by Manufacturer: 09/09/2021; 10/04/2021
• Initial Report FDA Received Date: 07/09/2021
• Supplement Report FDA Received Date: 09/23/2021; 10/13/2021
• 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