MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. SPINNING SPIROS CLOSED MALE LUER, RED CAP; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number CH2000S-C

Device Problem Fluid/Blood Leak (1250)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/14/2020

Event Type  malfunction  

Manufacturer Narrative

The device was not returned for evaluation.Without the return of the sample a comprehensive failure investigation cannot be performed, and a cause cannot be determined.

Event Description

The event occurred on an unspecified date and involved a spinning spiros® closed male luer, red cap that leaked an unknown chemotherapy from the proximal end of spiros resulting in the infusion being stopped.There was a patient involvement and no report of adverse event.

Manufacturer Narrative

H10 - one used bag spike with clave, list# unknown, lot# unknown connected to one used list# ch2000s-c, spinning spiros (lot# 4981626) connected to one used partial cut iv set, manufacturer unknown, and three new list# ch2000s-c, spinning spiros (lot# 4981626), one new bd alaris pump set were received and visually inspected.Each of the new spiros sister samples were leak tested.No leakage observed from the three new samples.The one used spiros sample was leak tested and leakage was observed from the poppet tip/male luer nose interface.The used spiros was disassembled and deformation on the internal diameter of the male luer of the spiros was observed that would attribute to the leakage observed.The reported complaint can be confirmed on the one spiros.The probable cause is due to an interaction between the clave and the spiros.The device history review for lot number 4981626 was reviewed and there were no relevant non-conformances found that would have contributed to the reported complaint.Additional information can be found in section d10.

Manufacturer Narrative

Initial reporter from section e1 of ufmw ¿ clarissa wells; phone #: (b)(6).Additional contact person from section f4 and f5 of ufmw ¿ (b)(6).Additional information can be found in section a2, a3, b3, b5, f2, and g2.

Event Description

A medsun mandatory medwatch report (uf/importer report# 0533050000-2021-8020) was received which stated: "rn attached spiros cap with c-clip to primary tubing and then connected the end of the tubing to the luer lock (where chemo flushes are inserted).Immediately after, chemo back flowed through the luer-lock, spiros cap and leaked through the proximal end of the spiros cap.Registered surgical nurse (rsn) was notified.The device was disposed of as leaking chemotherapy.The care team met with the manufacturer representative to review the case.This is all the information available".It was also reported that the event occurred at the hospital.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, RED CAP
• Type of Device: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 11086699
• MDR Text Key: 234224613
• Report Number: 9617594-2020-00546
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 00840619026615
• UDI-Public: (01)00840619026615(17)250901(10)4981626
• Combination Product (y/n): N
• PMA/PMN Number: K082806
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup,Followup
• Report Date: 12/09/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: CH2000S-C
• Device Lot Number: 4981626
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/06/2021
• Date Manufacturer Received: 03/05/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Treatment: C-CLIP, MFR ICU MEDICAL.; UNSPEC PRIMARY ADMINISTRATION SET, MFR UNK.
• Patient Age: 3 YR