MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD SOLOMED¿ SYRINGE; PISTON SYRINGE

Catalog Number 302633

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.There were multiple lot numbers reported to be involved.The information for each lot number is as follows: d.4.Medical device lot #: 2073245.D.4.Medical device expiration date: 28-feb-2027.H.4.Device manufacture date: 14-mar-2022.D.4.Medical device lot #: 2073242.D.4.Medical device expiration date: 28-feb-2027.H.4.Device manufacture date: 14-mar-2022.D.4.Medical device lot #: 2077110.D.4.Medical device expiration date: 31-mar-2027.H.4.Device manufacture date: 18-mar-2022.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 plunger separated from the bd solomed¿ syringe while aspirating medicine.It was unspecified whether the event took place with lot 2073245, 2073242 or 2077110.This complaint was created to capture the 2nd of 2 related incidents.The following information was provided by the initial reporter, translated from portuguese: "customer has received complaints after market in which the end users report the syringe that goes inside the drug pack was defective in its plunger.In first occurrence, the user reports the plunger is jammed, rigid, so it was not able to aspirate the medication; in the other two occurrences, the user report that when the medication was being aspirated the plunger detached.The company also reports that the syringes are received sealed and are manually stored inside the cartons, so the odds of the issue happening inside their company (during production) are low, since there are no steps in their process that would compromise the integrity of the syringes.The batches affected in each event are unknown, but syringes' batches used in company production were: 2073245, 2073242 and 2077110.

Event Description

It was reported that the plunger separated from the bd solomed¿ syringe while aspirating medicine.It was unspecified whether the event took place with lot 2073245, 2073242 or 2077110.This complaint was created to capture the 2nd of 3 related incidents.The following information was provided by the initial reporter, translated from portuguese: "customer has received complaints after market in which the end users report the syringe that goes inside the drug pack was defective in its plunger.In first occurrence, the user reports the plunger is jammed, rigid, so it was not able to aspirate the medication; in the other two occurrences, the user report that when the medication was being aspirated the plunger detached.The company also reports that the syringes are received sealed and are manually stored inside the cartons, so the odds of the issue happening inside their company (during production) are low, since there are no steps in their process that would compromise the integrity of the syringes;.The batches affected in each event are unknown, but syringes' batches used in company production were: 2073245, 2073242 and 2077110.".

Manufacturer Narrative

H6: investigation summary since no samples displaying the condition reported are available for examination, we were unable to fully investigate this incident, therefore a root cause could not be determined.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.

• Brand Name: BD SOLOMED¿ SYRINGE
• Type of Device: PISTON SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba 81460 ; BR 81460
• Manufacturer Contact: jennifer suh ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 17507383
• MDR Text Key: 321057803
• Report Number: 3003916417-2023-00215
• Device Sequence Number: 1
• Product Code: FMF
• Combination Product (y/n): N
• Reporter Country Code: BR
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/31/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 302633
• Device Lot Number: SEE H10
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/31/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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