MAUDE Adverse Event Report: BECTON DICKINSON MEDICAL SYSTEMS 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 5 ML SYRINGE, 100 USP UNITS/ML; PREFILLED HEPARIN FLUSH SYRINGE

Catalog Number 306515

Device Problem Microbial Contamination of Device (2303)

Patient Problems Unspecified Infection (1930); Itching Sensation (1943); Skin Discoloration (2074)

Event Date 04/05/2018

Event Type  Injury  

Manufacturer Narrative

Fda notified: the fda was made aware of this incident via voluntary medwatch mw5077277.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 a patient had a routine bandage change on his picc line.The line was flushed with a 5 ml bd posiflush¿ heparin lock flush syringe, in 5 ml syringe, 100 usp units/ml at the patient's home.The patient experienced intense itching and went to an infusion center where the picc line was removed.The patient was evaluated by his primary care physician who prescribed an oral antibiotic and topical cream.The patient also experienced biceps discoloration, scaly dry skin, and an infection.As of the bd awareness date, the patient's symptoms remain unresolved and a follow up appointment had been scheduled with his pcp.Out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium.Bd was notified by the u.S.Food and drug administration (fda) and centers for disease control and prevention (cdc) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and cdc identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.Cdc¿s initial investigation found that affected patients had received treatment using certain bd flush products.To date, there is no evidence of bd flush product testing positive for this bacterium.Investigations are ongoing by bd, fda, and cdc.

Manufacturer Narrative

Additional information: contacted patient via phone call 07-jun-18 in which it was stated that the reaction symptoms, extreme itching in three localized locations on arm, began the day after using the flush and continue to this day.No cultures were taken to confirm infection.The pt noted that the staff at infusion said that the picc line was infected upon visual inspection.The pt was undergoing chemotherapy treatments at the time.Pt stated that the picc line was removed as a result of the infection which resulted in the cancellation of chemo treatments (lung cancer).Pt stated that he was told by his primary physician that chemo treatments will not be resumed.Investigation summary: lot number 716571n for product code (b)(4) was provided for evaluation by our quality engineer team along with one representative sample.As a retained sample investigation of 120 units was performed, returned samples were not required for this evaluation.Upon reviewing the production history for the provided lot number, no deviations or non-conformances were identified during the manufacturing process.A corrective and preventive action plan was initiated to further investigate and monitor this issue.One-hundred and twenty retained samples for the lot number provided were visually inspected and no abnormalities were observed in regards to the solution.A review of all lot sterility testing performed for product released between april 2015 and june 2018 confirmed that no organism growth was identified for any lots released during the shelf-life of this product.Multiple samples produced before and after the provided lot number were sent for sterility testing and confirmed that no microbial growth was exhibited after incubation.This in combination with the daily environmental monitoring and sterility testing provides confidence in the sterility of the reported lot number.The root cause analysis of the reported infection cases under capa (b)(4) has not identified a direct causation between the infections and the bd franklin product.

Event Description

It was reported that a patient had a routine bandage change on his picc line.The line was flushed with a 5 ml bd posiflush¿ heparin lock flush syringe, in 5 ml syringe, 100 usp units/ml at the patient's home.The patient experienced intense itching and went to an infusion center where the picc line was removed.The patient was evaluated by his primary care physician who prescribed an oral antibiotic and topical cream.The patient also experienced biceps discoloration, scaly dry skin, and an infection.As of the bd awareness date, the patient's symptoms remain unresolved and a follow up appointment had been scheduled with his pcp.*out of an abundance of caution and in the interest of public health, bd voluntarily recalled certain lots of bd posiflush¿ heparin lock flush and bd¿ pre-filled normal saline flush syringes due to a potential for contamination with serratia marcescens bacterium.Bd was notified by the u.S.Food and drug administration (fda) and centers for disease control and prevention (cdc) about a potential epidemiological link between catheter related blood stream infections and the s.Marcescens bacterium.Specifically, the fda and cdc identified a potential connection between reports of infection in a small number of patients caused by s.Marcescens across multiple states.Cdc¿s initial investigation found that affected patients had received treatment using certain bd flush products.To date, there is no evidence of bd flush product testing positive for this bacterium.Investigations are ongoing by bd, fda, and cdc.

• Brand Name: 5 ML BD POSIFLUSH¿ HEPARIN LOCK FLUSH SYRINGE, IN 5 ML SYRINGE, 100 USP UNITS/ML
• Type of Device: PREFILLED HEPARIN FLUSH SYRINGE
• Manufacturer (Section D): BECTON DICKINSON MEDICAL SYSTEMS; 9630 south 54th street; franklin WI 53132
• MDR Report Key: 7571441
• MDR Text Key: 110172042
• Report Number: 2134319-2018-00038
• Device Sequence Number: 1
• Product Code: FOZ
• UDI-Device Identifier: 30382903065159
• UDI-Public: 30382903065159
• Combination Product (y/n): N
• PMA/PMN Number: K011967
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,other
• Type of Report: Initial,Followup
• Report Date: 08/10/2018

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?: No
• Device Operator: Other
• Device Expiration Date: 06/23/2019
• Device Catalogue Number: 306515
• Device Lot Number: 716571N
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 05/17/2018
• Initial Date FDA Received: 06/05/2018
• Supplement Dates Manufacturer Received: 05/17/2018
• Supplement Dates FDA Received: 08/10/2018
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention