MAUDE Adverse Event Report: CFN MEXICO 215 SA DE CV GRAVITY SET 10DP CKV 2SMS DEHP FREE; INTRAVASCULAR ADMINSTRATION SET

Model Number 47177E

Device Problem Leak/Splash (1354)

Patient Problem Overdose (1988)

Event Date 06/22/2020

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 Description

It was reported that gravity set 10dp ckv 2sms dehp free roller clamp failed.The following information was provided by the initial reporter: material no.: (b)(4), batch no.: unknown.It was reported that the roller clamp failed.

Manufacturer Narrative

It was reported that there was a defective roller clamp.Received from the customer is one used gravity set model 47177e lot unknown.The set was visually inspected for kinks, incomplete bonding engagements, holes/tears in the tubing or damages to the components.No anomalies were observed with the received set.Functional testing was performed by filling a lab iv bag with blue dye water and attaching it to the sets allowing fluid to flow through the whole set via gravity.Fluid flowed freely and showed no signs of leaking.During gravity testing the roller clamp was engaged and fluid flow stopped as expected.The roller clamp was engaged and disengaged multiple times.Each time the fluid flow stopped completely as intended.Device history record for model 47177e could not be performed due to no lot number being provided by customer.The customer¿s report that the roller clamp failed was not confirmed.Functional priming found no anomalies with the received set.During gravity testing the roller clamp was engaged and fluid flow stopped as expected.The roller clamp was engaged and disengaged multiple times.Each time the fluid flow stopped completely as intended.H3 other text : see h10.

Event Description

It was reported that gravity set 10dp ckv 2sms dehp free roller clamp failed.The following information was provided by the initial reporter: material no.: 47177e batch no.: unknown it was reported that the roller clamp failed.

• Brand Name: GRAVITY SET 10DP CKV 2SMS DEHP FREE
• Type of Device: INTRAVASCULAR ADMINSTRATION SET
• Manufacturer (Section D): CFN MEXICO 215 SA DE CV; parque industrial el florido.; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10252052
• MDR Text Key: 200028587
• Report Number: 9616066-2020-02147
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 10885403235436
• UDI-Public: 10885403235436
• Combination Product (y/n): N
• PMA/PMN Number: K952760
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other,user facility
• Type of Report: Initial,Followup
• Report Date: 06/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/09/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 47177E
• Device Catalogue Number: 47177E
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/26/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other