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

Catalog Number 990147

Device Problem Physical Resistance/Sticking (4012)

Patient Problem Hyperglycemia (1905)

Event Date 03/23/2023

Event Type  malfunction  

Manufacturer Narrative

D.4.Medical device expiration date: unknown.H.4.Device manufacture date: unknown.H.3.A device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.

Event Description

It was reported while using bd plastipak¿ syringes the medication could not be delivered.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: the son of a dog's caregiver got in touch saying that he bought 40 plastipak syringes to apply insulin to his pet.On tuesday, the 21st of march, he was applying the insulin and noticed that the insulin did not completely come out of the syringe.He realized that the pet's blood glucose was still high, this whole week he tested 9 syringes and all are hard with difficulty to apply, it only releases 40% of the insulin when squeezing, informed the notifier.

Manufacturer Narrative

H.6.Investigation summary: no physical samples were received however the investigation was performed based on the photo(s) provided.Embecta was unable to duplicate or confirm the indicated issue and based on trend analysis no further action is required at this time.Complaints received for this device and reported condition will continue to be tracked and trended.If samples are received in the future the complaint will be reopened for further investigation.Based on the above, no additional investigation and no corrective/preventative action (capa) or situation analysis (sa) is required at this time.

Event Description

It was reported while using bd plastipak¿ syringes the medication could not be delivered.This occurred twice.There was no report of patient impact.The following information was provided by the initial reporter, translated from portuguese to english: the son of a dog's caregiver got in touch saying that he bought 40 plastipak syringes to apply insulin to his pet.On tuesday, the 21st of march, he was applying the insulin and noticed that the insulin did not completely come out of the syringe.He realized that the pet's blood glucose was still high, this whole week he tested 9 syringes and all are hard with difficulty to apply, it only releases 40% of the insulin when squeezing, informed the notifier.

• Brand Name: BD PLASTIPAK¿ SYRINGES
• 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: phillip emmert ; 9450 south state street; sandy, UT 84070 ; 8448235433
• MDR Report Key: 16716563
• MDR Text Key: 313400831
• Report Number: 3003916417-2023-00079
• Device Sequence Number: 1
• Product Code: FMF
• UDI-Device Identifier: 07891463000859
• UDI-Public: (01)07891463000859
• 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,Consumer
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial,Followup
• Report Date: 08/17/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/11/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: 990147
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 08/17/2023
• 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