MAUDE Adverse Event Report: SISTEMAS MEDICOS ALARIS, S.A. DE C.V. BD SMARTSITE¿ 13MM VIAL ACCESS DEVICE; INTRAVASCULAR ADMINISTRATION SET

Model Number 2203E

Device Problem Packaging Problem (3007)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 11/15/2022

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.

Event Description

It was reported that the bd smartsite¿ 13mm vial access device had a hole/puncture in the overwrap.The following information was provided by the initial reporter: our analytical team had an observation of the packaging of the vial adapter before design verification testing and wanted to meet with bd to discuss if this observation has been seen before.At a high level, the packaging has a hole/ puncture in the overwrap.

Manufacturer Narrative

The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 27-dec-2022.H6: investigation summary one sample was submitted for quality investigation.The customer complaint of packaging issue-product packaging was verified by visual inspection and evaluation.The sample submitted were subjected to visual inspection under magnification.The sample showed signs of damage to the clear plastic packaging.The damage seen were small holes in the packaging that varied in shape and sizes.Further examination of the issue in relation to the product showed that the damage in the packaging was always on the side of the packaging where the large opening side of the product would be located.Additional evaluation was conducted in order to determine if the plastic packaging could be punctured by the internal spike of the product.Although the spike is sharp enough to puncture the plastic packaging, it did not seem feasible that the spike punctured the plastic packaging because in order for the plastic packaging to be damaged by the spike, it would have to forcefully pushed into the spike, stretching the plastic packaging more than it would be stretched in a normal use situation.Further investigation into the types of holes seen, showed that some of the holes looked to be longer in length and represented more like tears in the packaging rather than holes.With this in mind, a test was done to see if stacking the product in the packaging and pressing down on the stack, would cause a tear in the plastic packaging.The test was successful, and a tear was created in the packaging that was similar to the tears seen in the sample examined.A device history record review for model 2203e lot number 22075476 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Based on the findings of the investigation, the probable root cause of the issue lies in the packaging of the product.An investigation was conducted at the manufacturing and packaging facilities and it was determined that the samples corresponding to the complaint reported by the customer, were sealed without using spacers or using the orientation fixture and therefore there is a relationship between the damage reported by the customer and the forming process under conditions that cause the film to become thinner.

Event Description

It was reported that the bd smartsite¿ 13mm vial access device had a hole/puncture in the overwrap.The following information was provided by the initial reporter: our analytical team had an observation of the packaging of the vial adapter before design verification testing and wanted to meet with bd to discuss if this observation has been seen before.At a high level, the packaging has a hole/ puncture in the overwrap.

• Brand Name: BD SMARTSITE¿ 13MM VIAL ACCESS DEVICE
• Type of Device: INTRAVASCULAR ADMINISTRATION SET
• Manufacturer (Section D): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer (Section G): SISTEMAS MEDICOS ALARIS, S.A. DE C.V.; blvd. insurgentes no. 20351; parque industrial el florido; tijuana
• Manufacturer Contact: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 15928894
• MDR Text Key: 308097795
• Report Number: 9616066-2022-01879
• Device Sequence Number: 1
• Product Code: FPA
• UDI-Device Identifier: 27613203013851
• UDI-Public: (01)27613203013851
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K970485
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 01/26/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/06/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Model Number: 2203E
• Device Catalogue Number: 2203E
• Device Lot Number: 22075476
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/26/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/07/2022
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1