MAUDE Adverse Event Report: BECTON DICKINSON DE MEXICO BD PLASTIPAK ¿ STERILE SYRINGE; PISTON SYRINGE

Catalog Number 302558

Device Problem Material Separation (1562)

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

Event Date 07/26/2023

Event Type  malfunction  

Manufacturer Narrative

B.3.Date of event: unknown.The date received by manufacturer has been used for this field.H.3.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 needle separated from the bd plastipak ¿ sterile syringe while the medication was being prepared.The following information was provided by the initial reporter, translated from spanish: "it is reported that a quality problem was detected in the code 302558 10 ml syringe with needle, since "when the medication was being prepared, the needle came off the syringe and remained inside the medication vial".

Event Description

No additional information received.It is reported that a quality problem was detected in the code 302558 10 ml syringe with needle, since "when the medication was being prepared, the needle came off the syringe and remained inside the medication vial." catalog: 302558 description: 10 ml syringe with 21g x 32mm needle supplier lot: 2326610 quantity received: (b)(4) pieces invoice: (b)(4) reception date: (b)(6) 2023 quantity returned: 1 piece based on the foregoing, we request that: ¿ be aware ¿ the corresponding internal actions are taken ¿ we are notified of the action plan including the root cause the follow-up will be given with the complaint code (b)(4).

Manufacturer Narrative

Photo received for investigation.Through visual inspection, the needle hub is observed without the cannula, therefore the incident is confirmed.Furthermore, a device history record review showed no rejected inspections or quality issues during the production of the provided lot number that could have contributed to the reported defect.Based on the teams investigation, possible root cause is associated with insufficient application of epoxy in the assembly of the cannula-hub.Epoxy is a white adhesive used to join the cannula with the hub.Monthly preventive maintenance plan the change of the epoxy dosing valve of the nip line will be added.

Manufacturer Narrative

Customer provided to us the additional information below.((b)(6) (b)(6) 2023) was there any harm to the patient / healthcare professional due to the incident? (detail) there was no harm to the patient.What drug was being tampered with? he doesn't remember the name of the medicine.Was there exposure of medication or chemotherapy to the mucous membranes or the skin of the health professional? (detail) there was no exposure of the medication to the skin, since the needle remained inside the vial.Information reviewed [nazreenaida].

Event Description

Additional information received.It is reported that a quality problem was detected in the code 302558 10 ml syringe with needle, since "when the medication was being prepared, the needle came off the syringe and remained inside the medication vial." catalog: 302558 description: 10 ml syringe with 21g x 32mm needle supplier lot: 2326610 quantity received: (b)(4) pieces invoice: (b)(4) reception date: (b)(6) 2023 quantity returned: 1 piece based on the foregoing, we request that: ¿ be aware ¿ the corresponding internal actions are taken ¿ we are notified of the action plan including the root cause the follow-up will be given with the complaint code (b)(4) ____ customer provided to us the additional information below.- was there any harm to the patient / healthcare professional due to the incident? (detail) there was no harm to the patient.- what drug was being tampered with? he doesn't remember the name of the medicine.- was there exposure of medication or chemotherapy to the mucous membranes or the skin of the health professional? (detail) there was no exposure of the medication to the skin, since the needle remained inside the vial.

• Brand Name: BD PLASTIPAK ¿ STERILE SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer (Section G): BECTON DICKINSON DE MEXICO; autopista; 55 59 99 8400, k.m. 37.5; cuautitlan izcalli
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17514277
• MDR Text Key: 321055765
• Report Number: 9614033-2023-00077
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: MX
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 11/20/2023

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 Catalogue Number: 302558
• Device Lot Number: 2326610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/26/2023
• Initial Date FDA Received: 08/11/2023
• Supplement Dates Manufacturer Received: 10/30/2023; 10/30/2023
• Supplement Dates FDA Received: 10/30/2023; 11/20/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/15/2023
• 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