MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA BD LL ECLIPSE NEEDLE

Catalog Number 30281664

Device Problem Inaccurate Information (4051)

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

Event Date 10/02/2021

Event Type  malfunction  

Manufacturer Narrative

(b)(6).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 ll eclipse needle experienced a mix of product types in a pack.The following information was provided by the initial reporter: found inside the 40x1,2 needle package (disposable hypodermic eclipse needle w/ 40mmx1,2mm safety device - ref.30281664).Another needle size corresponding to a 13x0.4mm needle - (eclipse model desc hypodermic needle with safety device 13mm x 0.4mm - ref.30281264).It was packed, with the same batch, validity and was attached to the other 40x12, the difference in separation was observed for a kit that would be assembled in the sector.

Manufacturer Narrative

H.6.Investigation: photos received for investigation, upon visual inspection the failure is confirmed.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.As verified in the production history, the possible cause of the occurrence was related to an operational failure during setup and line cleaning, where a needle from the previous catalog (1.20x40) was packed in a batch of 0.40x13 needles.H3 other text : see h.10.

Event Description

It was reported that the bd ll eclipse needle experienced a mix of product types in a pack.The following information was provided by the initial reporter: found inside the 40x1,2 needle package (disposable hypodermic eclipse needle w/ 40mmx1,2mm safety device - ref.30281664).Another needle size corresponding to a 13x0.4mm needle - (eclipse model desc hypodermic needle with safety device 13mm x 0.4mm - ref.30281264).It was packed, with the same batch, validity and was attached to the other 40x12, the difference in separation was observed for a kit that would be assembled in the sector.

• Brand Name: BD LL ECLIPSE NEEDLE
• Type of Device: NEEDLE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer (Section G): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• Manufacturer Contact: katie swenson ; 9450 south state street; sandy, UT 84070 ; 8015296192
• MDR Report Key: 12755994
• MDR Text Key: 282114755
• Report Number: 3003916417-2021-00336
• Device Sequence Number: 1
• Product Code: FMI
• 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,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/22/2021

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: 30281664
• Device Lot Number: 1243497
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/08/2021
• Initial Date FDA Received: 11/06/2021
• Supplement Dates Manufacturer Received: 11/22/2021
• Supplement Dates FDA Received: 12/14/2021
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/21/2021
• 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