MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. GEM BURETTE V/NV 60DP PS 3SS DEHP FREE; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	2447-0007
Medical Device Problem Code	Device Contamination with Chemical or Other Material (2944)
Health Effect - Clinical Code	No Patient Involvement (2645)
Date of Event	07/27/2020
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.
Event or Problem Description
It was reported that the gem burette v/nv 60dp ps 3ss dehp free experienced foreign matter contamination.The following information was provided by the initial reporter: i am going to speak with the caregiver that turned it in, but wanted to bring it to your attention.This was placed in my door last night ((b)(6)).This is what was found with they went to take the cap off of the spike straight out of the package.I am going to verify that she hadn't been using betadine, because that is honestly the only other thing i can think of and we haven't found any others with this.Additional information (customer response): i spoke with the nurse who found the issue with this product.I asked if she had been using betadine prior to opening the packaging or if any of the surfaces had betadine on them.She stated that she was wearing a clean pair of gloves, no one was using betadine nor was there betadine on any of the surfaces, and they were spiking a bag of fluid for a peripheral iv not a central line.The nurse opened the packaging went to remove the spike cap and saw the brown residue immediately, so placed it back in the package and then into my box.She said the next product she opened was clean, so she spiked and hung the fluid with no harm to the infant.I will sending the product via (b)(6) either this evening or tomorrow early afternoon.
Event or Problem Description
It was reported that the gem burette v/nv 60dp ps 3ss dehp free experienced foreign matter contamination.The following information was provided by the initial reporter: i am going to speak with the caregiver that turned it in, but wanted to bring it to your attention.This was placed in my door last night (7/27).This is what was found with they went to take the cap off of the spike straight out of the package.I am going to verify that she hadn¿t been using betadine, because that is honestly the only other thing i can think of and we haven¿t found any others with this.Additional information (customer response): i spoke with the nurse who found the issue with this product.I asked if she had been using betadine prior to opening the packaging or if any of the surfaces had betadine on them.She stated that she was wearing a clean pair of gloves, no one was using betadine nor was there betadine on any of the surfaces, and they were spiking a bag of fluid for a peripheral iv not a central line.The nurse opened the packaging went to remove the spike cap and saw the brown residue immediately, so placed it back in the package and then into my box.She said the next product she opened was clean, so she spiked and hung the fluid with no harm to the infant.I will sending the product via fedex either this evening or tomorrow early afternoon.
Additional Manufacturer Narrative
The customer reported that the tubing spike was contaminated when taken straight out of the package.The customer provided a photo showing a spike tip having brownish colored markings along it.Next to the spike tip was a package for 2447-0007 lot 20056758.Received was what looked to be an unused infusion burette set model 2447-0007 with package lot 20056758.Visual inspection of the set immediately observed brownish colored markings along the side of the quickspike component p/n 11689721 (supplier p/n pf0473).No similar markings were observed anywhere else along the set and no other obvious issue was noted with the set.The markings were attempted to be wiped off.It was observed that the markings were able to be wiped off.No functional testing was necessary due to the immediate observation of the reported issue.The device history record for model 2447-0007 lot 20056758 shows that the sample was manufactured on 25may2020 for a total of(b)(4) units.There were no quality notifications issued during the production build of this set.The customer's report that the tubing spike was contaminated was confirmed.The root cause has been determined to be a result of the supplier process in which the quickspike component has come into contact with grease used in the molding machinery.H3 other text : see h10.

• Brand Name: GEM BURETTE V/NV 60DP PS 3SS DEHP FREE
• Common Device Name: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.; blvd. insurgentes 20351; tijuana, null 22244 ; MX 22244
• MDR Report Key: 10422653
• Report Number: 9616066-2020-02523
• Device Sequence Number: 19606425
• Product Code: FPA
• UDI-Device Identifier: 10885403235078
• UDI-Public: 10885403235078
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K944320
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2020

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: 05/25/2023
• Device Catalogue Number: 2447-0007
• Device Lot Number: 20056758
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/03/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 10/05/2020
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: 20200727; 20200727
• Outcome Attributed to Adverse Event: Other