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	20130-01
Medical Device Problem Codes	Crack (1135); Fluid/Blood Leak (1250)
Health Effect - Clinical Codes	No Consequences Or Impact To Patient (2199); Chemical Exposure (2570)
Date of Event	09/09/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Concomitant medical products: decarbazine, mfr unk; primary plumset, ln 14687-28, mfr icu medical; secondary set, ln 14299-28, mfr icu medical; safestep huber needle, 20g x1.0 in, ln lh-0032, mfr bard.The complaint leakage and cracks on the returned one (1) used list# 20130-01, spinning spiros could not be confirmed.As received, the set was leak tested per product specification.There were no leaks anywhere along the fluid path.There were no crack, damages or anomalies anywhere along the device.The returned list# 20130-01, spinning spiros met product specification.A device history review for lot# 4590588 and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.
Event or Problem Description
A sus voluntary event report (# mw5096571) was received on october 6, 2020 that stated: "the spiros that was attached to the iv tubing had a crack in it and caused the chemotherapy medication that was being infused to leak onto the patient¿s skin.¿ additional information was received stating that there were no issues noted during initial set-up/priming.The medication infusing was decarbazine 610mg in 100ml of normal saline and was administered at a rate of 100ml per hour.After the device had infused for 5 to 10 minutes, a leak of about 15ml was noted on the patient¿s shirt.A new spiros was placed on the primary line and the infusion was resumed.The location of the crack was in the spiros body, poppet, half seal subassembly.The mating devices used were a primary plumset, secondary set, and huber needle.It was reported that the chemo leak did not bother the patient and there was no redness or injury to the skin.The skin was cleansed and rinsed with water and there were no further complaints from the patient.

• Brand Name: SPINNING SPIROS CLOSED MALE LUER, RED CAP
• Common Device Name: 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: 10758000
• Report Number: 9617594-2020-00468
• Device Sequence Number: 1138068
• Product Code: FPA
• UDI-Device Identifier: 00840619023386
• UDI-Public: (01)00840619023386(17)250101(10)4590588
• Combination Product (Y/N): N
• Initial Reporter State: NV
• Initial Reporter Country: US
• PMA/510(K) Number: K082806
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 10/06/2020

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: 01/01/2025
• Device Catalogue Number: 20130-01
• Device Lot Number: 4590588
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/13/2020
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/06/2020
• Initial Report FDA Received Date: 10/29/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1