MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. 6 INCH HEP LOCK EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	20035E
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	11/07/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
Event or Problem Description
It was reported that two 6 inch hep lock ext sets could not aspirate or were difficult to draw.The following information was provided by the initial reporter: material #: 20035e, batch/ lot #: 20076261.Manager from er, let me know her staff put in a voice about the 6 inch set extension subs we have been getting.They say that these are too stiff and do not work and patients are complaining about them as well.Substitution item - smart site extension site are terrible.Not first time had difficulty w/ item.Today, unable to draw blood off site w/use of 2 different luer locks, then attempted to flush extension tubing w/saline to save iv site and would not flush (in mean time, pt bleeding on floor).Able to ask for assistance of another staff member to get different extension set, other supplies needed to save iv/get labs needed will not use this item again unless absolutely necessary as each time have had difficulty of some kind -pt c/o pain as tubing to stiff and pulls on iv site, difficulty getting syringe to connect.
Event or Problem Description
It was reported that two 6 inch hep lock ext sets could not aspirate or were difficult to draw.The following information was provided by the initial reporter: material #: 20035e, batch/ lot #: 20076261.Manager from er, let me know her staff put in a voice about the 6 inch set extension subs we have been getting.They say that these are too stiff and do not work and patients are complaining about them as well.Substitution item - smart site extension site are terrible not first time had difficulty w/ item.Today, unable to draw blood off site w/use of 2 different luer locks, then attempted to flush extension tubing w/saline to save iv site and would not flush (in mean time, pt bleeding on floor).Able to ask for assistance of another staff member to get different extension set, other supplies needed to save iv/get labs needed will not use this item again unless absolutely necessary as each time have had difficulty of some kind -pt c/o pain as tubing to stiff and pulls on iv site, difficulty getting syringe to connect.
Additional Manufacturer Narrative
The following information has been updated/corrected: d.10.Device available for evaluation?: yes.D.10.Date returned to manufacturer?: 2020-11-19.H.3.Device returned to manufacturer?: yes.H.3.Device evaluated by manufacturer?: yes.H.6 investigation summary: one sample was received for quality investigation.The customers complaint of tubing defective / damaged could not be verified by testing and investigation.The sample received was visually inspected and showed no physical defects or damages.The sample was then leak tested and the clamp was tested in multiple locations.The tubing did not show any damages after the clamp was engaged, released and then leakage tested again.A device history record review for model 20035e, lot number 20076261 was performed.The search showed that a total of (b)(4) in 1 lot number was built on 15jul2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.No root cause could be established because the issue of the tubing being too stiff could not be verified.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H.6.Method codes: 10, 3331.Result codes: 213.Conclusion codes: 4315.H3 other text : see h10.

• Brand Name: 6 INCH HEP LOCK EXT SET
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana 22244 ; MX 22244
• MDR Report Key: 10962352
• Report Number: 9616066-2020-20525
• Device Sequence Number: 14240442
• Product Code: FPA
• UDI-Device Identifier: 07613203011990
• UDI-Public: 07613203011990
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: other,user facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 12/08/2020

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: Other
• Device Expiration Date: 07/15/2023
• Device Catalogue Number: 20035E
• Device Lot Number: 20076261
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/19/2020
• Initial Date Received by Manufacturer: 11/10/2020
• Supplement Date Received by Manufacturer: 11/10/2020
• Initial Report FDA Received Date: 12/07/2020
• Supplement Report FDA Received Date: 12/18/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1