MAUDE Adverse Event Report: COVIDIEN 30376 VIAL VENTING CHEMO PIN

Model Number DP5201V

Device Problem Particulates (1451)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

Submit date: 01/01/2016.An investigation is currently under way; upon completion the results will be forwarded.

Event Description

It was reported to covidien on (b)(6) 2016 that a customer had an issue with a vial venting chemo pin.The customer states after puncture with the chemo pin and extracting the product, particles were found in the syringe.

Manufacturer Narrative

There was no lot number provided with this complaint; therefore, it was not possible to complete a review of the lot history.One used sample was returned with this complaint received at the manufacturing.The sample returned was packaged in a plastic zip bag.The bag contained the bottle of red liquid with the vial vent installed along with the syringe.The plastic bag was in a red sharps container.Further investigation into the contents of the bottle found it is a highly regulated chemotherapy drug posing risk to anyone exposed to the fumes or liquid.It will require special hazardous materials disposal.Because of the hazardous nature of the liquid in the vial and the vent, the ability to safely analyze the product for a root cause is severely limited.The returned materials including the product sample were visually inspected for contamination or particles.None were seen floating or suspended in liquid or within the product sample.The product is manufactured by a subcontractor who also analyzed the pictures taken to see if the product was the cause of the reported failure.The vendor was not able to see any contamination in the pictures supplied to them.Additionally, the subcontractor does not think there is possibility for a residue or product particles to have come from the manufacturing process.The reported condition is not confirmed.The returned product would meet quality release specifications based on the lack of any evidence for which the complaint was registered.The vial vent is designed to capture any particles blown back at the preparer as fluid is introduced in a rubber capped vial with a syringe.The spike on the vial vent contains two channels.The fluid goes down in one channel to reconstitute the lyophilized compound and this pressurizes the interior of the vial which will blow back particles going up the other channel and are trapped in the filter.The complaint states that particles were observed in the vial vent after use which confirms that the device worked as intended.The complaint also states that particles were observed in the syringe after the reconstituted compound had been drawn from the vial through the vial vent.The complaint then states that the syringe was not inspected before use but it also states that the syringe contained no particles before use.These two statements are incompatible.The syringe was either inspected before use and particles were/were not observed or it was not inspected before use and therefore there is no credible way of knowing that the syringe did not contain particles before use.There is only one way that particles can get into the device except the way the device was intended to be used and that is if the weld that holds the filter between the two molded parts is imperfect.Such a problem has never been reported and if this was the case, the device would have leaked through the weld and any particle from the outside would still be trapped by the filter.The filter received from the complainant did not leak and thus had an intact weld.If any particles actually passed through the filter, they must be smaller than 0.2 and would not be observable by the naked eye.The subcontractor's conclusion is that the dp5201v chembloc vial vent did not cause particles to appear in the syringe.There is therefore no need for any corrective action by the subcontractor.Why particles observable by the naked eye were observed in the syringe is beyond the scope of this response and will not be speculated on.Prior to a lot¿s release, the lot must be deemed acceptable by passing inspections that are based on a valid sampling plan.Inspectors routinely examine a statistical sample both physically and visually.No corrective and preventative actions are required.The reported condition could not be confirmed, thus no containment actions will be implemented.This complaint will be used for tracking and trending purposes.

• Brand Name: 30376 VIAL VENTING CHEMO PIN
• Type of Device: VIAL VENTING CHEMO PIN
• Manufacturer (Section D): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer (Section G): COVIDIEN; 1430 marvin griffin road; augusta GA 30906
• Manufacturer Contact: edward almeida ; 15 hampshire st; mansfield, MA 02048 ; 5084524151
• MDR Report Key: 5691366
• MDR Text Key: 47305093
• Report Number: 1018120-2016-00078
• Device Sequence Number: 1
• Product Code: LHI
• Combination Product (y/n): N
• Reporter Country Code: CA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 05/03/2016

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
• Device Operator: Other
• Device Model Number: DP5201V
• Device Catalogue Number: DP5201V
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 05/03/2016
• Initial Date FDA Received: 06/01/2016
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/30/2016
• Is the Device Single Use?: Yes
• Type of Device Usage: Unknown
• Patient Sequence Number: 1