MAUDE Adverse Event Report: BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V. BD CONNECTA¿ STOPCOCK

Catalog Number 394600

Device Problem Contamination /Decontamination Problem (2895)

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

Event Date 03/13/2019

Event Type  malfunction  

Manufacturer Narrative

(b)(4).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 a bd connecta¿ stopcock had foreign matter which was presume to be blood before use.The following information was provided by the initial reporter: ¿foreign material presumed to be blood.Before the package is opened, the product is covered in red.".

Manufacturer Narrative

Investigation: the device history record (dhr) review was performed for the lot number 8278804 material ns394600 identified in the complaint 854545.According to the documented records, the product was manufactured according to the approved manufacturing procedures, specifications, and then released by quality assurance.The sample was received in flks during (b)(6) 2019 and the ftir analysis was performed on the dark material (fm) observed on the surface of the sample.The spectral analysis suggests that this material has components similar to those of blood.The samples was visual inspected in nogales site confirming the blood on device.Conclusion(s): bd was not able to duplicate the customer¿s indicated failure mode.Unfortunately our manipulation to this product is limited.We received molded components from sandy and those components are unloaded into the bowl feeders on equipment ka60 to do the automatic assembly and then in an automatic mode is move into fa60 for packaging purposes.Once is packaged is loaded manually into the shelf/case cartons.The reason to have it automated is that we need to keep a low bio burden to ensure that the e-beam sterilization is efficient.Maintenance records were reviewed and reveals major adjustments that can contribute on this issue were not performed.The safety record was reviewed and no injury/near-miss were reported during the manufacture of the complaint lot.The procedure nqs3-0231sp requires cleanness in every shift change and give to the operator the instructions to follow this activity.This procedure indicates the use of tool of hard plastic (fixture) without edges to remove any stuck part in the machine and to clean nest.All the personal (operators/inspector/technicians/mechanics) used gloves during all manufacturing process and when handling products, during maintenance process or any machine jam, as part or procedure nqs3-0231sp.The procedure nqs3-0231sp requires all the personal must be cover any exposed injury.The procedure opm407sp and opm328sp indicates to the operator all the risk operations and the instructions required to perform this operations.Quality records have been consulted for tracking and trending purposes and no issues like this are detected which means no other occurrences.All personnel involved on this process are properly trained.We will keep monitoring the manufacturing process and in case any emerging trend is detected, further actions will be taken if necessary.Process fmea rm5979, rm5978 and peura eurap2053001, eurap2053014 were reviewed and there are proper controls in place to detect product contamination.Investigation at sandy, ut: molding dhr was reviewed for components collar nut, housing, protection cap, 3 arm tap and luer plug.There was no blood contamination noted.On august 21 at 12:45 at press d15, one of the associates got hit on the head while setting up the press and was bleeding.He exited out the roll-up door next to press d15 and did not re-enter any clean room.He did not pass by any other press.The protection cap was being molded on press d07 in the same row as the accident, but 7 presses separated it from the accident.The complaint sample does not have any blood on the protection cap, but on the collar nut and housing components.If blood had dripped onto one of the protection caps during the molding process, it most likely would have dried up before reaching nogales and not transferred to another component(s).There were no extended stoppages.The molding presses are stopped every 24 hours to perform a cleaning of the mold face.There are requirements in molding that no one is allowed to touch the molded parts either with their bare hands or gloves.A robot and end of arm tool is used with the stopcock housing and collar nut molds.This tool picks the parts from the mold face and drops them in a collection cart where the parts go down a chute into a bag.The only time the parts are exposed to human contact is when the operator takes the bag out to close it.Operators are instructed not to touch the parts.Any maintenance on the press or mold does not expose these parts to risk of fluid contact.Based on investigation results to date, team concluded that blood contamination in device could be potentially occasioned by the following possible root cause: injuries occasioned by sharp edges in machine ka60 and fa60 capa#889156 has been initiated.

Event Description

It was reported that a bd connecta¿ stopcock had foreign matter which was presume to be blood before use.The following information was provided by the initial reporter: ¿ foreign material presumed to be blood.Before the package is opened, the product is covered in red.¿.

• Brand Name: BD CONNECTA¿ STOPCOCK
• Type of Device: STOPCOCK
• Manufacturer (Section D): BD INFUSION THERAPY SYSTEMS INC. S.A. DE C.V.; periferico luis donaldo; colosio no. 579; nogales
• MDR Report Key: 8474580
• MDR Text Key: 141057855
• Report Number: 9610847-2019-00264
• Device Sequence Number: 1
• Product Code: FMG
• Combination Product (y/n): N
• PMA/PMN Number: N/A
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,other,user facility
• Type of Report: Initial,Followup
• Report Date: 05/02/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/02/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 09/30/2021
• Device Catalogue Number: 394600
• Device Lot Number: 8278804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2019
• Date Manufacturer Received: 03/14/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other