MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C. 20 INCH EXT SET; INTRAVASCULAR ADMINISTRATION SET

Catalog Number	C20022
Medical Device Problem Codes	Difficult to Remove (1528); Difficult or Delayed Separation (4044)
Health Effect - Clinical Code	No Information (3190)
Date of Event	08/06/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patients date of birth is unknown; their age was used to calculate the place holder date of (b)(6).Date of event: unknown.The date received by manufacturer has been used for this field.Device expiration date: unknown.Device lot #: an invalid lot # of 200056797 was provided.Device manufacture date: unknown.
Event or Problem Description
It was reported that the 20 inch ext set experienced difficulty disconnecting the device which caused the picc to be removed.The following information was provided by the initial reporter: the tubing was placed directly into a lumen of a picc and not into the needleless connector.Customer response 25-aug-2020: are you able to provide a part no and batch no for the reported extension tubing? ref# c20022 lot# (10)20056787.Was there any adverse event(s) as a result of the reported defect? yes pt.¿s picc line had to be removed prematurely.
Event or Problem Description
It was reported that the 20 inch ext set experienced difficulty disconnecting the device which caused the picc to be removed.The following information was provided by the initial reporter: the tubing was placed directly into a lumen of a picc and not into the needleless connector.Customer response 25-aug-2020: ¿ are you able to provide a part no and batch no for the reported extension tubing? ref# (b)(4) lot# (10)20056787; ¿ was there any adverse event(s) as a result of the reported defect? yes pt.¿s picc line had to be removed prematurely.
Additional Manufacturer Narrative
The following fields were updated due to additional information: d.10 device available for eval yes.D.10 returned to manufacturer on: 08/31/2020.Investigation conclusion.It was reported that the male piece from the extension tubing broke off in the picc line.Received from the customer is one used extension model c20022 lot 20056797.Attached to the set¿s female luer is a maxzero connector model mz1000-07 lot unknown.The set was visually inspected for cracks, misassemblies or damages to the components.Visual inspection found that the male luer (p/n 600117) tip of the set was broken off.Closer inspection under a lab microscope observed stress marks at the break site.No tool marks were observed.Equipment used for testing on 21sep2020: ¿ optical ram-cnc eq 08204 5-feb-21.A device history record for model c20022 with lot number 20056797 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on 25may2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of the break is due to excessive outside force on the male luer as indicated by the visible stress marks observed on the broken male luer tip.The root cause of the outside force could not be determined.

• Brand Name: 20 INCH EXT SET
• 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: 10468519
• Report Number: 9616066-2020-02662
• Device Sequence Number: 3257075
• Product Code: FPA
• UDI-Device Identifier: 10885403235498
• UDI-Public: 10885403235498
• Combination Product (Y/N): N
• Initial Reporter State: ID
• Initial Reporter Country: US
• PMA/510(K) Number: K790108
• 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): 08/06/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Other
• Device Catalogue Number: C20022
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2020
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/28/2020
• Supplement Report FDA Received Date: 10/19/2020
• 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: MZ1000-07.
• Outcome Attributed to Adverse Event: Other
• Patient Age: 67 YR
• Patient Weight: 55