MAUDE Adverse Event Report: BECTON, DICKINSON AND CO. BD POSIFLUSH¿ SF SALINE SYRINGE; INTRAVASCULAR CATHETER

Model Number 306553

Device Problem Packaging Problem (3007)

Patient Problem No Patient Involvement (2645)

Event Date 03/30/2020

Event Type  malfunction  

Manufacturer Narrative

Investigation summary: a device history record review was performed for provided lot number 9143529 and the review did not reveal any detected quality issues during the production process that could have contributed to this reported incident.To aid in the investigation of this issue, both physical samples and picture samples were provided for evaluation by our quality engineer team.Through examination of the returned samples, the presence of brown stains on the packaging was identified.It has been determined that this incident resulted from the steam sterilization process.We are currently exploring several options to reduce and eliminate any brown staining that occurs on the packaging.Investigation conclusion: the returned samples and photos confirmed the presence of foreign matter/brown stains on packaging.The non-conformance's were reviewed for this batch and there was no record of non-conformance associated with this batch.Root cause description: based on the investigation, the root cause of this complaint was created during the steam sterilisation process.The root cause of this complaint was created during the steam sterilisation process.The integrity of the product and the sterile barriers have not been affected.These spots appear only on the outside of the packaging and do not permeate in any way onto the product.Furthermore, microbial permeability testing, cytotoxicity testing, and testing for residual solvents and volatile species has been completed on the packages displaying the brownish stain.The testing confirmed that they do not present any risk to the use of the product and have no impact on the effectiveness, sterility, quality or safety of bd posiflush¿ sf 10ml saline flush syringe.Rationale: based on the investigation, no additional investigation and no capa is required at this time.

Event Description

It was reported that 22 bd posiflush¿ sf saline syringes were found with discolored primary packaging units before use.The following information was provided by the initial reporter: "we have discovered contamination on 22 each 306553 syringe saline prefilled 10ml, lot # 9143529, 02/25/20 po 146473 line 20.".

• Brand Name: BD POSIFLUSH¿ SF SALINE SYRINGE
• Type of Device: INTRAVASCULAR CATHETER
• Manufacturer (Section D): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer (Section G): BECTON, DICKINSON AND CO.; donore road; drogheda
• Manufacturer Contact: brett wilko ; 9450 south state street; sandy, UT 84070 ; 8015652341
• MDR Report Key: 9975372
• MDR Text Key: 193263553
• Report Number: 9616657-2020-00060
• Device Sequence Number: 1
• Product Code: NGT
• UDI-Device Identifier: 30382903065531
• UDI-Public: 30382903065531
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153481
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,other
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 04/02/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/17/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Expiration Date: 04/30/2022
• Device Model Number: 306553
• Device Catalogue Number: 306553
• Device Lot Number: 9143529
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/10/2020
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2020
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 05/23/2019
• 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
• Patient Outcome(s): Other