MAUDE Adverse Event Report: COVIDIEN CHEMOPLUS; CONTAINER, I.V.

Model Number	CP3005A
Medical Device Problem Code	Problem with Sterilization (1596)
Health Effect - Clinical Code	No Patient Involvement (2645)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4): product analysis was created by the (b)(4) lab as part of the receipt process, so that decontamination could be documented in (b)(6).This product analysis activity is being marked as ¿complete¿ and the investigating site will create another product analysis activity upon receipt.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
Event or Problem Description
The customer states that the product sticks to the side of the bag or the syringe and the foil on top it tears or its hard to remove.
Additional Manufacturer Narrative
A sample consisting of two single iva seals on their liner were submitted for analysis.The two samples were fully intact on their bottom liner.The iva seals have adhesive on them so that they will stick securely to the medical device they are being used for.The adhesive properties as described in the complaint show that the adhesive is working as intended in the design of the product.As part of our packaging process the first seal on the roll is lifted up to secure the end of roll in place to the clam shell.The seals were slowly peeled from their liner, the seals peeled away as they should.The seals have perforated design so that they will tear if an individual was to attempt to tamper with the sealed medical device.The quality engineer attempted to manually tear a seal with a finger nail and hands on a non-perforated area of the seal, and no tearing occurred.When tearing at the perforation tearing would occur at the start of the perforation and would continue further into the seal as the perforation tear worked as it was intended.The results of the manufacturing facility investigation were able to determine that the product is working as intended.There were no changes to any components in the production of these seals to work in a different fashion from previous lots; there will always be lot to lot variation in adhesiveness.The complaint will be unconfirmed.No formal corrective or preventive actions will be taken at this time.If additional information or samples are received, the investigation will resume as needed.We will continue to trend this issue for future occurrences as part of the complaint review process.If information is provided in the future, a supplemental report will be issued.

• Brand Name: CHEMOPLUS
• Common Device Name: CONTAINER, I.V.
• Manufacturer (Section D): COVIDIEN; 2 ludlow park dr; chicopee MA 01022 1318
• MDR Report Key: 6880234
• Report Number: 1219103-2017-05017
• Device Sequence Number: 761610
• Product Code: KPE
• UDI-Device Identifier: 10884527005857
• UDI-Public: 10884527005857
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: user facility
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 02/13/2018

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 Expiration Date: 10/25/2020
• Device Model Number: CP3005A
• Device Catalogue Number: CP3005A
• Device Lot Number: 633714X
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/31/2017
• Initial Date Received by Manufacturer: 08/23/2017
• Supplement Date Received by Manufacturer: 08/23/2017
• Initial Report FDA Received Date: 09/20/2017
• Supplement Report FDA Received Date: 02/13/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1