MAUDE Adverse Event Report: CAREFUSION ALARIS PCA MODULE SETS; SET, ADMINISTRATION, INTRAVASCULAR

Model Number	10800173
Medical Device Problem Code	Tear, Rip or Hole in Device Packaging (2385)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The affected product has been received and the investigation is pending.A follow up report will be submitted once the failure investigation has been completed.Requested patient demographics however not provided by the customer.
Event or Problem Description
The customer reported the pca set was punctured.The event occurred in the oncology unit.Although requested there are no additional details provided at this time.There was no indication of patient harm.A noted received with the product documented; "date adm (b)(6) 2019".
Event or Problem Description
The customer reported the pca set was "punctured".The event occurred in the oncology unit.Although requested there are no additional details provided at this time.There was no indication of patient harm.A noted received with the product documented; "date adm (b)(6) 2019".
Additional Manufacturer Narrative
The customer¿s report the pca set was "punctured" was confirmed.Visual inspection of the set noted a cut in the suspect pca tubing approximately 2 inches below the antisiphon valve.There were no other anomalies observed.Functional testing confirmed leaking from the tubing approximately 2 inches below the antisiphon valve.Closer inspection of the leak under magnification observed a cut in the tubing that is approximately 0.151 in long.The root cause of the cut could not be identified.
Additional Manufacturer Narrative
Correction on initial report d.4: disregard lot # 11611800.
Event or Problem Description
The customer reported the pca set was "punctured".The event occurred in the oncology unit.Although requested there are no additional details provided at this time.There was no indication of patient harm.A noted received with the product documented ; "date adm (b)(6) 2019".

• Brand Name: ALARIS PCA MODULE SETS
• Common Device Name: SET, ADMINISTRATION, INTRAVASCULAR
• Manufacturer (Section D): CAREFUSION; 10020 pacific mesa blvd; san diego CA 92121 4386
• MDR Report Key: 8382090
• Report Number: 9616066-2019-00553
• Device Sequence Number: 312457
• Product Code: FPA
• UDI-Device Identifier: 10885403234385
• UDI-Public: 10885403234385
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K960280
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,other
• Initial Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 02/07/2019

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 Model Number: 10800173
• Device Catalogue Number: 10800173
• Device Lot Number: 11611800
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/27/2019
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 03/01/2019
• Supplement Report FDA Received Date: 07/01/2019; 07/05/2019
• 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: 2420-0007, THERAPY DATE UNK; 2420-0007, THERAPY DATE UNK