MAUDE Adverse Event Report: ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V. MICROCLAVE® CLEAR NEUTRAL CONNECTOR; SET, ADMINISTRATION, INTRAVASCULAR

Catalog Number	12512-01
Medical Device Problem Code	Disconnection (1171)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	06/25/2019
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device is expected to return for evaluation.It has not been received.
Event or Problem Description
The event involved a microclave® clear neutral connector that was reported to come off the line when the hub was scrubbed or a flush was done when the flush is screwed on using a threaded luer slip.The patient was restless the night of the occurrence and coband was used to protect the line so it would not come off.It was reported the connector disconnected from the male end of the microclave even with coband covering the site.The line was being used for routine chemotherapy and lab draws with flushes.There was no blood loss reported.It was also reported that the iv therapy nurse found the clave attached to the line of an intermittent infusion.The customer stated that the patient sustained an infection and there was a delay of many hours to replace the peripherally inserted central catheter (picc) line because the clave was missing.
Additional Manufacturer Narrative
H10 - two used list# 12512-01, microclave¿ clear neutral connectors, lot# 93-672-jw, one used catheter powerpicc solo, manufacturer bard, one syringe 0.9% sodium chloride, manufacturer monoject, two unused list# 12512-01, microclave¿ clear neutral connectors, and one unused list# 2420-0500, bd alaris pump infusion set were received for evaluation on 8/16/2019.The microclave connectors and mating devices were measured and found to be design and iso compatible.The microclave connectors connected as per iso test procedure pressure leak tested with the bard powerpicc solo catheter without leakage or disconnect.The complaint was unable to be confirmed after testing and evaluation.A device history review (dhr) for lot# 93-672-jw and relevant commodities were reviewed, and no non-conformances were found that would have contributed to the reported complaint.D11 ¿ updated information: powerpicc solo catheter, manufacturer bard; syringe 0.9% sodium chloride, manufacturer monoject; bd alaris pump infusion set, list# 2420-0500.Additional information can be found in section d11 and g1.

• Brand Name: MICROCLAVE® CLEAR NEUTRAL CONNECTOR
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): ICU MEDICAL DE MEXICO, S. DE R.L. DE C.V.; avenida cuarzo no. 250; colonia rancho santa clara, ma; ensenada, b.cfa. 22790 ; MX 22790
• MDR Report Key: 8893651
• Report Number: 9617594-2019-00268
• Device Sequence Number: 1400509
• Product Code: FPA
• UDI-Device Identifier: 00887709050532
• UDI-Public: (01)00887709050532(17)230901(10)93-672-JW
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: K100434
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2019

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: 09/01/2023
• Device Catalogue Number: 12512-01
• Device Lot Number: 93-672-JW
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: 07/30/2019
• Supplement Date Received by Manufacturer: 08/26/2019
• Initial Report FDA Received Date: 08/14/2019
• Supplement Report FDA Received Date: 08/28/2019
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 63 YR