MAUDE Adverse Event Report: BECTON DICKINSON IND. CIRURGICAS LTDA SYRINGE PLASTIPAK 20ML LL S/SU

Catalog Number 990687

Device Problem Fungus in Device Environment (2316)

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

Event Date 08/07/2019

Event Type  malfunction  

Manufacturer Narrative

Date of event: unknown.The date received by manufacturer has been used for this field.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 syringe plastipak 20 ml ll s/su experienced mold presence which was noted during use.The following information was provided by the initial reporter: there is a foreign matter similar to mold inside the syringe.Information received by email on (b)(6) 2019: the defect was noticed in during use.

Event Description

It was reported that the syringe plastipak 20ml ll s/su experienced mold presence which was noted during use.The following information was provided by the initial reporter: there is a foreign mattter similar to mold inside the syringe.Information received by email on (b)(6)2019 : the defect was noticed in during use.

Manufacturer Narrative

H.6.Investigation summary: dhr, quality notification and maintenance analysis were reviewed and no occurrences potentially related to the incident was observed.Photos and sample were provided for incident.It was possible observe the presence of foreign matter at syringe body ¿ can be evaluated as dirt.Conclusion: after the photo and sample evaluation it was possible identify the fm complaint as a dirt residue from the stopper feeding system.This way the potential cause for the issue is an operational failure at stopper feeding system cleaning.The operators will be notified from this complaint.H3 other text : see section h.10.

• Brand Name: SYRINGE PLASTIPAK 20ML LL S/SU
• Type of Device: SYRINGE
• Manufacturer (Section D): BECTON DICKINSON IND. CIRURGICAS LTDA; 550 rua cyro correia pereira; curitiba
• MDR Report Key: 8931551
• MDR Text Key: 155653362
• Report Number: 3003916417-2019-00417
• Device Sequence Number: 1
• Product Code: FMF
• 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: 10/23/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 12/31/2023
• Device Catalogue Number: 990687
• Device Lot Number: 8354857
• Initial Date Manufacturer Received: 08/07/2019
• Initial Date FDA Received: 08/26/2019
• Supplement Dates Manufacturer Received: 08/07/2019
• Supplement Dates FDA Received: 10/23/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other